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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73776

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

Open FDA event record

Event summary

Timeline bucket
March 04, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips Medical Systems (Cleveland) 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

3 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 3

Extended Brilliance Workspace NM Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.

Z-1504-2016
Recall number
Z-1504-2016
Initiated
March 04, 2016
Classification
Class II
Status
Terminated
Quantity
126 Units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another. However, certain gamma cameras allow for other relative detector angles. Data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro and the results will likely be erroneous.

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

The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another. However, certain gamma cameras allow for other relative detector angles. Data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro and the results will likely be erroneous.

Code information

M/N 882489; S/N: 66794, 66798, 66836, 66009,66011, 67154, 66828, 67058, 67050, 67031, 67284, 66332, 66335, 66397, 67026, 67040, 66084, 66089, 66092, 67007, 67011, 67226, 66956, 66454, 66447, 66413, 66129, 66128, 66300, 66023, 11728, 66000, 66938, 67270, 67252, 66571, 66443, 66324, 66869, 68477, 66682, 66815, 66284, 67263, 66265, 66277, 66880, 66892, 66258, 66079, 66181, 66451, 66627, 66187, 66806, 67016, 67008, 66706, 66745, 66817, 66822, 66910, 66908, 66811, 67087, 67094, 66241, 66825, 66632, 66624, 66854, 66689, 66690, 66906, 66792, 67173, 67069, 67166, 68290, 67182, 66785, 67292, 67286, 66768, 66769, 66550, 66113, 67220, 67193, 67186, 66657, 66668, 66564, 66065, 67065, 67208, 67204, 66818, 66819, 67122, 66818, 66819, 66456, 67212, 66019, 67057, 67172, 67157, 67167, 67162, 66737, 68361, 66183, 66368, 66387, 66376, 66415, 66136, 66137, 66960, 66958, 67142 & 67165.

Distribution pattern

Worldwide Distribution -- US, including the states of CO, DE, FL, GA, IL, IN, KS, MO, NC, NV, NY, OH, OR, PA, TN & TX; and, the countries of Australia, Austria, Belgium, Canada, China, Denmark, Egypt, France, Germany, Greece, Ireland, Israel, Italy, Lebanon, Malaysia, Saudi Arabia, Slovenia, South Africa, Switzerland, Turkey, & United Kingdom.

device · product 2 of 3

Extended Brilliance Workspace NM Special Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.

Z-1505-2016
Recall number
Z-1505-2016
Initiated
March 04, 2016
Classification
Class II
Status
Terminated
Quantity
37 Units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another. However, certain gamma cameras allow for other relative detector angles. Data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro and the results will likely be erroneous.

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

The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another. However, certain gamma cameras allow for other relative detector angles. Data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro and the results will likely be erroneous.

Code information

M/N 882488; S/N: 66565, 66586, 66589, 66670, 66681, 66672, 66644, 66888, 66374, 66371, 66305, 66824, 66261, 66356, 66059, 66056, 67027, 66248, 66590, 66240, 66097, 66268, 66555, 66500, 66754, 66469, 66411, 66252, 66263, 66307, 66311, 66310, 66306, 66259, 67054, 67000 & 67017.

Distribution pattern

Worldwide Distribution -- US, including the states of CO, DE, FL, GA, IL, IN, KS, MO, NC, NV, NY, OH, OR, PA, TN & TX; and, the countries of Australia, Austria, Belgium, Canada, China, Denmark, Egypt, France, Germany, Greece, Ireland, Israel, Italy, Lebanon, Malaysia, Saudi Arabia, Slovenia, South Africa, Switzerland, Turkey, & United Kingdom.

device · product 3 of 3

IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.

Z-1506-2016
Recall number
Z-1506-2016
Initiated
March 04, 2016
Classification
Class II
Status
Terminated
Quantity
33 Units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another. However, certain gamma cameras allow for other relative detector angles. Data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro and the results will likely be erroneous.

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

The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another. However, certain gamma cameras allow for other relative detector angles. Data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro and the results will likely be erroneous.

Code information

M/N 881001; S/N: 85254, 82202, 85330, 82117, 7000022, 105009, 970001, 850001, 870030, 82141, 95068, 87182, 87197, 95078, 82140, 11017, 98139, 95035, 87200, 980047, 85314, 85303, 980046, 85298, 822022, 7000019, 950076, 950115, 95043, 95047, 950021, 960123 & 105006.

Distribution pattern

Worldwide Distribution -- US, including the states of CO, DE, FL, GA, IL, IN, KS, MO, NC, NV, NY, OH, OR, PA, TN & TX; and, the countries of Australia, Austria, Belgium, Canada, China, Denmark, Egypt, France, Germany, Greece, Ireland, Israel, Italy, Lebanon, Malaysia, Saudi Arabia, Slovenia, South Africa, Switzerland, Turkey, & United Kingdom.

Field note

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