Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 12, 2014
Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476)
The PET Reconstruction Server (PRS) database may randomly lock up after the low dose CT acquisition is complete and will not allow the PET acquisition to begin, resulting in an un…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips Medical Systems (Cleveland) Inc recalled Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEM… - a moderate-severity action.
Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEM… was recalled by Philips Medical Systems (Cleveland) Inc in February 12, 2014. Reason: The PET Reconstruction Server (PRS) database may randomly lock up after the low dose CT acquisition is comple…. Check the official notice for the remedy. Verify recall #Z-0932-2014 with the FDA Devices before acting.
The recall
Philips Medical Systems (Cleveland) Inc issued this moderate-severity FDA Devices recall-The PET Reconstruction Server (PRS) database may randomly lock up after the low dose CT acquisition is comple….
- Moderate
- severity level
- 386 units
- affected scope
- Class II
- classification
- February 12, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0932-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0932-2014) was formally reported on February 12, 2014, with the manufacturer initiating the action on December 4, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Philips Medical Systems (Cleveland) Inc is listed as the recalling firm, operating out of Cleveland, OH. Federal records list the affected scope as 386 units.
The documented reason for this recall is: The PET Reconstruction Server (PRS) database may randomly lock up after the low dose CT acquisition is complete and will not allow the PET acquisition to begin, resulting in an unexpected incomplete study. Distribution data in the federal record shows the product reached: Product was shipped to the following states: AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, NY , OH, OR, PA, TN, TX, VA, VT, WA & WI. Product was also shipped …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
386 units
Related Recalls
6
3 from same agency
Product description
Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476)
Reason for recall
The PET Reconstruction Server (PRS) database may randomly lock up after the low dose CT acquisition is complete and will not allow the PET acquisition to begin, resulting in an unexpected incomplete study.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0932-2014 |
| Date reported | February 12, 2014 |
| Date initiated | December 4, 2013 |
| Recalling firm | Philips Medical Systems (Cleveland) Inc |
| Firm location | Cleveland, OH |
| Affected scope | 386 units |
| Distribution | Product was shipped to the following states: AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, NY , OH, OR, PA, TN, TX, VA, VT, WA & WI. Product was also shipped to the following cou… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0932-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476). Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 386 units.
Why was this product recalled? ▼
The PET Reconstruction Server (PRS) database may randomly lock up after the low dose CT acquisition is complete and will not allow the PET acquisition to begin, resulting in an unexpected incomplete study.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 12, 2014. Severity: Moderate. Recall number: Z-0932-2014.
Where was the recalled product distributed? ▼
Distribution: Product was shipped to the following states: AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, NY , OH, OR, PA, TN, TX, VA, VT, WA & WI. Product was also shipped to the following countries: Australia, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Cuba, Denmark, Egypt, France, Germany, Hong Kong, Hungary, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malta, Mexico, Netherlands, Pakistan, Philippines, Poland, Portugal, Republic of Korea, Russia, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, Ukraine, United Kingdom, Venezuela & Vietnam..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0932-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 12, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.