Recalls / —

—#25458

Product

Philips BV300 Mobile X-Ray System

FDA product code

IZL — System, X-Ray, Mobile

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K953910

Affected lot / code info

Part numbers 9896 000 06801 and 9806 000 06802 with serial numbers: DBXXXX - all DBXXXX - all DDXXXX - all DEXXXX - all DG0001-DG0129 DH0001-DH0033 DJ0001 - DJ0152 DK0001 - DK 0076

Why it was recalled

The C-bow support can bend and break allowing C-arm to fall from support

Root cause (FDA determination)

Other

Action the firm took

The firm issued a letter dated 9/27/02 to their customers. The letter advised of the problem and that a service representative will visit to inspect unit and correct.

Recalling firm

Firm

Philips Medical Systems

Address

22100 Bothell Everett Highway, Bothell, Washington 98041

Distribution

Distribution pattern

The firm distributed to hospitals, x-ray centers and medical centers throughout the U.S.

Timeline

Recall initiated

2002-09-27

Posted by FDA

2003-02-01

Terminated

2005-01-12

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #25458. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.