ClearanceBrief
Recall Z-0097-04 ยท IZI System, X-Ray, Angiographic

Philips Medical Systems Sales & Service Region No. America

Monitor Ceiling Suspension for Fluoroscopic and Angiographic X-Ray Systems.

DateJul 20, 2004 (initiated Oct 10, 2003)
StatusTerminated
ReasonThe thumbscrew hinge pin on the monitor support arm could become loose allowing the monitor to fall.
Root causeOther
ActionThe firm issued a letter dated October 10, 2003 to all affected customers. The suspension will be upgraded by field service personnel starting October 24, 2003.
Quantity570 units
DistributionThe firm distributes to hospitals and medical centers.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K912470PHILIPS DIAGNOST 96
Philips Medical Systems, Inc., Aug 7, 1991
K923813PHILIPS INTEGRIS V3000 ROTATIONAL ANGIO FUNCTION
Philips Medical Systems, Inc., Oct 16, 1992