GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomo
FDA device recall Z-0197-2016 · posted 2015-11-02 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- The reason for this inspection is to determine if the Spindle Block Servo Controllers on the CT subsystem of potentially affected GEMINI PET/CT systems are susceptible to premature failure.
- Action taken
- Philips field service personnel will conduct customer visits in order to inspect systems. For further questions please call (440) 483-7600.
- Root cause
- Unknown/Undetermined by firm
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 264 units
- Distribution
- Worldwide Distribution - US Distribution to the states of : AL, AZ, CA, CO, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MO, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, WV, and
- Date initiated
- 2008-05-01
- Date posted
- 2015-11-02
- Date terminated
- 2015-11-06
- 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 RAPTOR (K052640) | Philips Medical Systems (Cleveland), Inc. | 2005-10-07 |
| GEMINI GXL (K051170) | Philips Medical Systems (Cleveland), Inc. | 2005-05-23 |
| GEMINI 16 (K032036) | Philips Medical Systems (Cleveland), Inc. | 2003-07-11 |