Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0586-03

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

Philips North America LLC / initiated 2003-01-10 / Terminated

Philips Medical Systems began a recall of MultiDiagnost 4 - x-ray system, multi functional/universal system for general use on . The reason FDA records is "INTERNAL SHORT CIRCUIT - MAY ALLOW FOR STAND AND TABLE TO MOVE SPONTANEOUSLY IN UPWARD OR DOWNWARD MOVEMENT". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0586-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Philips North America LLC
Product
MultiDiagnost 4 - x-ray system, multi functional/universal system for general use.
Product code
JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall
INTERNAL SHORT CIRCUIT - MAY ALLOW FOR STAND AND TABLE TO MOVE SPONTANEOUSLY IN UPWARD OR DOWNWARD MOVEMENT
FDA root cause
Other
Action
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
Quantity in commerce
22 units
Distribution
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.
Product codes and lots
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