ClearanceBrief
Recall Z-0852-06 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified

Philips Medical Systems North America Co. Phillips

MD4 X-ray system

DateMay 6, 2006 (initiated Apr 6, 2006)
StatusTerminated
ReasonPotential for unexpected table movement.
Root causeOther
ActionOn 4/6/06 the firm issued a letter to consignees advising of the problem. The letter advises consignees to conduct a test on their unit(s) for a possible short until the firm is able to upgrade the units.
Quantity100 units
DistributionUnits were distributed to hospitals and medical centers located throughou the US.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K961374PHILIPS MULTIDIAGNOST 4
Philips Medical Systems, Inc., Aug 19, 1996