The product is an isolation transformer, an accessory to Computed Tomography Scanner. It consists of electronic circuitr

FDA device recall Z-1234-2007 · posted 2007-09-13 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

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.

Action taken

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.

Root cause

Component design/selection

Status

Terminated

Product code

JAK

Quantity affected

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, Eg

Date initiated

2007-04-27

Date posted

2007-09-13

Date terminated

2012-03-02

Location

Cleveland, OH