Recalls / —

—#25769

Product

MultiDiagnost 4 - x-ray system, multi functional/universal system for general use.

FDA product code

JAA — System, X-Ray, Fluoroscopic, Image-Intensified

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K961374

Affected lot / code info

Serial numbers include (but are not limited to): 4584520996, 4594911196, 4595090397, 4595290697, 4594871196, 4594841196, 4595130197, 4615641197, 4595240797, 459500197, 4615511097, 4615581097, 4584570996, 4615320897, 459516497, 4595070197, 4584320996, 4584721096, 4615661197, 4594980197  Part numbers: 9896 000 58511, 9896 000 58512, 9896 000 58521, 9896 000 58522

Why it was recalled

INTERNAL SHORT CIRCUIT - MAY ALLOW FOR STAND AND TABLE TO MOVE SPONTANEOUSLY IN UPWARD OR DOWNWARD MOVEMENT

Root cause (FDA determination)

Other

Action the firm took

The firm issued a letter dated January 10, 2003 to their customers advising of the problem and that a respresentative would be contacting customers to arrange a time to visit to install new interface board. This is being conducted under FCO 70800007

Recalling firm

Firm

Philips Medical Systems

Address

22100 Bothell Everett Highway, Bothell, Washington 98041

Distribution

Distribution pattern

The firm distributed to 22 hospitals/medical centers located in CA, FL, IA, IL, IN, KY, MN, MO, NC, ND, NY, OH, SC, TN, TX, VA, and WV.

Timeline

Recall initiated

2003-01-10

Posted by FDA

2003-02-27

Terminated

2005-04-11

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #25769. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.