Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470,
FDA device recall Z-0932-2014 · posted 2014-02-04 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- 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.
- Action taken
- On 12/4/2013, the firm sent Field Safety Noticies to their customers.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 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 w
- Date initiated
- 2013-12-04
- Date posted
- 2014-02-04
- Date terminated
- 2016-02-02
- Location
- Cleveland, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GEMINI CONDOR (K081135) | Philips Medical Systems (Cleveland), Inc. | 2008-04-29 |
| GEMINI RAPTOR (K052640) | Philips Medical Systems (Cleveland), Inc. | 2005-10-07 |