—#71705

Product

General X-Ray System types with Digital Spot Imaging (DSI) software

FDA product code: IZJ — Camera, X-Ray, Fluorographic, Cine Or Spot
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K920793
Affected lot / code info: Software version: rel 6 serial numbers: 8, 18, 31, 40, 41, 45, 51, 52, 62, 63, 67, 71, 78, 79, 83, 84, 87, 88, 99, 100, 102, 104, 105, 106, 112, 116, 117, 118, 119, 127, 131, 132, 134, 136, 143, 146, 149, 153, 157, 163, and 164

Why it was recalled

X-ray images may be stored in the wrong patient file or corrupted, images from two different patients may be combined in one patient's folder or may be combined on one image (corrupted).

Root cause (FDA determination)

Software design

Action the firm took

On 5/20/08 the firm issued an URGENT - DEVICE CORRECTION letter to the consignees advising of the problem, requesting consignees to check the stored or printed images to ensure that it represents the data and images captured from the examination. The firm will issue a Field Change Order to their service representatives providing new software, when software is available. This should be issued by the end of June.

Recalling firm

Firm: Philips Medical Systems North America Co. Phillips
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2008-05-23
Posted by FDA: 2008-08-25
Terminated: 2010-09-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #71705. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.