GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH
FDA device recall Z-0979-2014 · posted 2014-02-12 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- 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.
- Action taken
- ON 12/5/2013 the firm sent Medical Device Correction Letters to their customers.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 47 Units
- Distribution
- 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,
- Date initiated
- 2013-12-05
- Date posted
- 2014-02-12
- Date terminated
- 2015-08-25
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GEMINI CONDOR (K081135) | Philips Medical Systems (Cleveland), Inc. | 2008-04-29 |