GEMINI TF Big Bore computer tomograph software version 3.6. Catalog #882476, Gantry S/N 9001-9023. The GEMINI TF Big Bor
FDA device recall Z-2915-2011 · posted 2011-08-01 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- Two non-safety related defects have been found on the Philips GEMINI TF Big Bore running version 3.6; if these defects were to recur, it could impact the performance or reliability of the system. Philips is issuing a software update to all Philips GEMINI TF Big Bore customers to correct these defects.
- Action taken
- Philips Medical Systems (Cleveland) Inc. sent an "GEMINI TF BIG BORE CPE CUSTOMER LETTER" dated October 20, 2011 to all affected customers. The letter describes the product, problem, and updates that are available to the customers. The letter provides additional information about acquisition workflows for SUV Calibrations and Validations. For support concerning this upgrade, contact the Customer Care Solutions Center at 1-800-722-9377.
- Root cause
- Software design (manufacturing process)
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 23 units
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of CO, LA, MD, MI, MO, MN, PA, TX, VA, VT and WI and the countries of Belgium, Germany, Italy, Saudi Arabia and Switzerland.
- Date initiated
- 2009-08-05
- Date posted
- 2011-08-01
- Date terminated
- 2012-09-21
- 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 |