TumorLoc software for the Brilliance Big Bore (BB) and the CT Extended Brilliance Workstation (EBW), Model #4550 116 024
FDA device recall Z-1542-2009 · posted 2009-07-13 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- A software error in the TumorLoc software was discovered upon receipt of a customer complaint. There is the potential for data to be lost during reconstruction of images in which slices can either be discarded, or interleaved based upon their series ID.
- Action taken
- Philips Medical issued an 'URGENT -Medical Device Correction' document dated January 28, 2009. This notification informs consignees of the TumorLoc imaging issue, the inherent hazards involved should this problem occur, the circumstances under which this problem may occur and corrective actions which the user/customer should perform in the event that this problem is encountered. It also informs that user/customer that Philips will have their Service Engineers contact the customers within 6 months to install a TumorLoc upgrade. For further questions, contact the Phillips Customer Care Center at 1-800-722-9377.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 356 units
- Distribution
- Worldwide Distribution - US, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Israel, Italy, Jordan, Libyan Ar
- Date initiated
- 2009-01-28
- Date posted
- 2009-07-13
- Date terminated
- 2012-09-19
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM (K033326) | Philips Medical Systems, Inc. | 2003-10-29 |