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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88665

10 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 26, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
GE Healthcare, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

10 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 10

SIGNA Premier nuclear magnetic resonance imaging system

Z-0132-2022
Recall number
Z-0132-2022
Initiated
August 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
11 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

Code information

Software version RX29.1 and RX27.3 (China only)

Distribution pattern

Distribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, TX, VA, WA, and Puerto Rico OUS distribution to: Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, UAE, and UK

device · product 2 of 10

SIGNA Architect nuclear magnetic resonance imaging system

Z-0133-2022
Recall number
Z-0133-2022
Initiated
August 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
2 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

Code information

Software version DV29.1; and DV28.4 (F), DV27.3 (T) (China only)

Distribution pattern

Distribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, TX, VA, WA, and Puerto Rico OUS distribution to: Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, UAE, and UK

device · product 3 of 10

SIGNA Pioneer nuclear magnetic resonance imaging system

Z-0134-2022
Recall number
Z-0134-2022
Initiated
August 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
5 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

Code information

Software version PX29.1; and PX25.4 (T), PX28.3 (China only)

Distribution pattern

Distribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, TX, VA, WA, and Puerto Rico OUS distribution to: Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, UAE, and UK

device · product 4 of 10

Discovery MR750w 3.0T nuclear magnetic resonance imaging system

Z-0135-2022
Recall number
Z-0135-2022
Initiated
August 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
13 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

Code information

Software version DV29.1

Distribution pattern

Distribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, TX, VA, WA, and Puerto Rico OUS distribution to: Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, UAE, and UK

device · product 5 of 10

Discovery MR750 3.0T nuclear magnetic resonance imaging system

Z-0136-2022
Recall number
Z-0136-2022
Initiated
August 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
5 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

Code information

Software version DV29.1

Distribution pattern

Distribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, TX, VA, WA, and Puerto Rico OUS distribution to: Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, UAE, and UK

device · product 6 of 10

SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system

Z-0137-2022
Recall number
Z-0137-2022
Initiated
August 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
6 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

Code information

Software version DV29.1

Distribution pattern

Distribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, TX, VA, WA, and Puerto Rico OUS distribution to: Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, UAE, and UK

device · product 7 of 10

SIGNA Voyager nuclear magnetic resonance imaging system

Z-0138-2022
Recall number
Z-0138-2022
Initiated
August 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
15 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

Code information

Software version VX29.1; and PX26.4 (China only)

Distribution pattern

Distribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, TX, VA, WA, and Puerto Rico OUS distribution to: Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, UAE, and UK

device · product 8 of 10

SIGNA Artist nuclear magnetic resonance imaging system

Z-0139-2022
Recall number
Z-0139-2022
Initiated
August 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
18 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

Code information

Software version DV29.1

Distribution pattern

Distribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, TX, VA, WA, and Puerto Rico OUS distribution to: Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, UAE, and UK

device · product 9 of 10

Optima MR450w 1.5T nuclear magnetic resonance imaging system

Z-0140-2022
Recall number
Z-0140-2022
Initiated
August 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
13 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

Code information

Software version DV29.1

Distribution pattern

Distribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, TX, VA, WA, and Puerto Rico OUS distribution to: Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, UAE, and UK

device · product 10 of 10

1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system

Z-0141-2022
Recall number
Z-0141-2022
Initiated
August 26, 2021
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
3 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

Code information

Software version HD29.1; and HD16.2 (China only)

Distribution pattern

Distribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, TX, VA, WA, and Puerto Rico OUS distribution to: Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, UAE, and UK

Field note

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