Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0270-04

Digital Diagnost VE

Philips North America LLC / initiated 2003-11-20 / Terminated

Philips Medical Systems Sales & Service Region No. America began a recall of Digital Diagnost VE on . The reason FDA records is "The support chain attachment on the detector carriage may fail and cause the counter weights or detector to fall". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0270-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Philips North America LLC
Product
Digital Diagnost VE
Product code
KPR System, X-Ray, Stationary
Reason for recall
The support chain attachment on the detector carriage may fail and cause the counter weights or detector to fall.
FDA root cause
Other
Action
The firm mailed a recall letter to affected customers on November 20, 2003 notifying them of the problem. The letter states upgrades will be completed by the end of April 2004.
Quantity in commerce
70 devices total
Distribution
The firm distributed to medical facilities nationwide.
Product codes and lots
Site numbers: 82652, 82681, 82723, 82730, 83073, 85495, 85696, 85697, 85698, 86222, 86382, 86383, 86987, 86988, 100572, 100806, 101933, 102030, 102100, 102115, 102116, 102117, 102489, 102539, 102596, 102713, 102717, 102719, 102787, 102905, 103109, 103165, 103262, 103271, 103272, 103436, 103437, 103438, 103439, 103453, 103511, 103778, 103893, 103894, 103953, 103971, 103976, 104014, 104338, 104465, 104578, 104673, 104676, 104864, 104902, 104903, 104904, 104937, 104938, 105158, 105198, 105199, 105322, 105367, 105415, X1641, X1642, X1650, X1767, X1768. The firm uses site numbers instead of serial numbers.