Philips GEMINI TF 16 Diagnostic CT X-ray/PET Imaging System, 510(k) #K052640. System units equipped with software versio
FDA device recall Z-0343-2012 · posted 2011-12-01 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- In response to complaints received by Philips Medical concerning certain identified software errors reported by their customers, the firm is conducting a recall/software correction to several of their GEMINI PET/CT X-ray system units in the field. The firm believes that if these software defects were to recur, it could impact the performance of reliability of the these PET/CT system units.
- Action taken
- Philips Healthcare sent a "CPE CUSTOMER LETTER" dated October 28, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Additionally, device operation information is provided to customers. A Philips Field Service Engineer will be visiting each customer site to install the necessary software upgrades. Contact the Customer Care Solutions Center at 1-800-722-9377 for questions concerning this notice.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 9 units
- Distribution
- Nationwide Distribution including the states of CO, LA, MD, MI, MN, PA, TX, VA, VT, and WI.
- Date initiated
- 2011-04-25
- Date posted
- 2011-12-01
- Date terminated
- 2013-02-22
- 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 |