—#111935

Product

Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications

FDA product code: MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K982795
Affected lot / code info: Lot or Serial Numbers With affected M-cabinet CXA; Serial number; 11-K0003; 12-B0001, 12-B0002; 12-B0003

Why it was recalled

Creepage Distance between the two primary phases in the GEO Transformer is 4.5 mm.does not meet (IEC) International standard of 5.5 mm.

Root cause (FDA determination)

Device Design

Action the firm took

Philips Healthcare Imaging issued an Urgent - Field Safety Notice dated August 8, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The unit will be exchanged with a new unit that complies with the IEC requirements. Please reference Field Change Order (FCO) 71200081 when contacting I your local Philips representative. 1-800-722-9377. Customer were instructed to review the information contained in the letter with all members of their staff who need to be aware of the contents of the letter and to maintain a copy of the letter with the equipment instruction for Use. For further assistance, customers should contact their local Phillips representative: Technical Support Line 1-800-722-9377. For questions regarding this recall call 978-687-1501.

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: Worldwide Distribution - USA including OH and WA and the country of Canada

Timeline

Recall initiated: 2012-08-14
Posted by FDA: 2012-09-14
Terminated: 2017-01-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #111935. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.