CLASS II Device recall · Reported 19 Feb 2014 · FDA Enforcement Report
Gemini TF Big Bore PET/CT, Computer Tomography System recalled
Philips Medical Systems (Cleveland) is recalling Gemini TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, distributed in 21 states. The recall was initiated on 5 Dec 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0979-2014
- FDA event ID
- 67305
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Dec 2013
- FDA classified
- 12 Feb 2014
- Reported
- 19 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 5 Dec 2013 | Recall initiated by company | |
| 12 Feb 2014 | Classified by FDA | +69 days |
| 19 Feb 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The TF Big Bore patient table experienced mechanical binding during horizontal table motion resulting in an automatic Emergency Stop (E-stop). An E-Stop will interrupt a current scan, resulting in an incomplete study.
Product as listed by the FDA
GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH
Where it was distributed
Product was shipped to the following states: AR, CA, CO, FL, IL, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, PA, TX, VA, VT & WI. Product was also shipped to the following countries: Belgium, Canada, China, Denmark, France, Germany, Italy, Japan, Netherlands, Saudi Arabia & Venezuela.
ArkansasCaliforniaColoradoFloridaIllinoisLouisianaMassachusettsMarylandMichiganMinnesotaMissouriNorth CarolinaNebraskaNew JerseyNew YorkOhioPennsylvaniaTexasVirginiaVermont
Questions about this recall
Why was it recalled?
The TF Big Bore patient table experienced mechanical binding during horizontal table motion resulting in an automatic Emergency Stop (E-stop). An E-Stop will interrupt a current scan, resulting in an incomplete study.
Which lots are affected?
Model #882476, Serial #'s: 9004, 9005, 9006, 9008, 9009, 9010, 9011, 9012, 9013, 9014, 9015, 9016, 9017, 9018, 9019, 9020, 9021, 9022, 9023, 9201, 9202, 9203, 9204, 9205, 9206, 9207, 9208, 9209, 9210, 9211, 9213, 9214, 9215, 9216, 9217, 9218, 9219, 9220, 9221, 9222, 9223, 9224, 9225, 9226, 9228, 9229, 9231.
Where was it sold?
Product was shipped to the following states: AR, CA, CO, FL, IL, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, PA, TX, VA, VT & WI. Product was also shipped to the following countries: Belgium, Canada, China, Denmark, France, Germany, Italy, Japan, Netherlands, Saudi Arabia & Venezuela.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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