Exact FDA event identifier

Event 81574

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

Event summary

Timeline bucket: November 06, 2018
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Deerfield Imaging, Inc.

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

4 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 4

IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, (d) 109682-600, (e) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient.

Z-0645-2019

Recall number: Z-0645-2019
Initiated: November 06, 2018
Classification: Class II
Status: Terminated
Recalling firm: Deerfield Imaging, Inc.
Quantity: 15 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Table may drift in the roll position while in use

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Table may drift in the roll position while in use

Code information

(a)108000-000, Serial Numbers: 10000983, 10000652 (b)108000-600, Serial Numbers: 06-0025, 10001306 (c)109682-000, Serial Numbers: 10002375, 10001118, 10001340 (d)109682-600, Serial Numbers: 10001119, 10001188, 10003634, 05-002, 10003638, 10003623, 10001305 (e)110470-600, Serial Numbers: 10006887

Distribution pattern

Worldwide distribution - US Nationwide and countries of China, Qatar, Canada, Australia, Japan, France, Germany, Sweden, Italy.

device · product 2 of 4

IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient.

Z-0646-2019

Recall number: Z-0646-2019
Initiated: November 06, 2018
Classification: Class II
Status: Terminated
Recalling firm: Deerfield Imaging, Inc.
Quantity: 27 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Table may drift in the roll position while in use

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Table may drift in the roll position while in use

Code information

(a) 110470-000, Serial Numbers: 10002845, 10002341, 10003629, 10003801, 10003830, 10002847, 10002796, 10003243, 10002654, 10003841, 10002607, 10007348, 10007424, 10005651, 10004250, 10004439, 10003241, 10006886, 10002848, 10006438, 10003007, 10004576, 10003245 (b) 110470-600, Serial Numbers: 10003244, 10003064, 10003244, 10002343

Distribution pattern

Worldwide distribution - US Nationwide and countries of China, Qatar, Canada, Australia, Japan, France, Germany, Sweden, Italy.

device · product 3 of 4

IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b) 113821-600, (c) 114148-000, (d) 114148-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient.

Z-0647-2019

Recall number: Z-0647-2019
Initiated: November 06, 2018
Classification: Class II
Status: Terminated
Recalling firm: Deerfield Imaging, Inc.
Quantity: 14 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Table may drift in the roll position while in use

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Table may drift in the roll position while in use

Code information

(a) 113821-000, Serial Numbers: 10002220 (b) 113821-600, Serial Numbers: 10002692, 10006152, 10007192, 10006991, 10003754, 10006997, 10004513 (c) 114148-000, Serial Numbers: 10004463, 10005190, 10005189, 10006891, 10004997 (d) 114148-600, Serial Numbers: 10006891

Distribution pattern

Worldwide distribution - US Nationwide and countries of China, Qatar, Canada, Australia, Japan, France, Germany, Sweden, Italy.

device · product 4 of 4

IMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) 114093-000, (b) 114093-006 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient.

Z-0648-2019

Recall number: Z-0648-2019
Initiated: November 06, 2018
Classification: Class II
Status: Terminated
Recalling firm: Deerfield Imaging, Inc.
Quantity: 14 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Table may drift in the roll position while in use

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Table may drift in the roll position while in use

Code information

(a) 114093-000, Serial Numbers: 10005695, 10002998, 10005456, 10007377, 10002997, 10005612, 10004372, 10002841 10002255, 10002385, 10005613 (b) 114093-006, Serial Numbers: 10007411, 10002996, 10004515

Distribution pattern

Worldwide distribution - US Nationwide and countries of China, Qatar, Canada, Australia, Japan, France, Germany, Sweden, Italy.