Recall Z-1234-2007 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
The product is an isolation transformer, an accessory to Computed Tomography Scanner. It consists of electronic circuitry enclosed in a metal case. According to Philips Medical Systems, the metal case is manufactured from self-extinguishing materials. The unit is labeled in part, "Power Conditioner *** Part Number 4450028-XX *** Frequency: *** S/N: *** Rev: *** MFG date: *** INPUT RATINGS *** M
| Date | Sep 13, 2007 (initiated Apr 27, 2007) |
| Status | Terminated |
| Reason | The TEAL Power Conditioning units may fail and result in the unit emitting fire and/or smoke. Note: the TEAL Power Conditioning Unit has the potential to fail when the scanner that is attached to the TEAL is powered and in use as well as when not in use. |
| Root cause | Component design/selection |
| Action | On 9/04/2007, Philips Medical Systems (PMS) sent a letter via courier to all affected customers. The letter notified customers about the failures of the TEAL power conditioner and the possible emisson of fire and/or smoke from the units. In addition, the letter notes that PMS implemented a Field Change Order in May, 2007 that directs onsite repair of all affected units by PMS service technicians. |
| Quantity | 491 |
| Distribution | Worldwide, including, USA, Canada, China, Italy, Russia, Brazil, Belgium, Germany, Austria, Australia, Netherlands, France, Korea, Denmark, Israel, England, Argentina, Mexico, Spain, Yemen, Greece, Egypt, Japan, UAE, & Chile. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.