ClearanceBrief
Recall Z-0331-2012 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

Toshiba American Medical Systems Inc

Model CAT-850B Catheterization Table, a component of the Toshiba INFX-8000 series X-Ray Interventional System. These systems are single or dual plane systems that employ x-rays to obtain fluoroscopy or radiography images of the body. The system is comprised of a computer system, support arms (that contain the tube and solid state detector), x-ray generator and a patient table. This device is a di

DateDec 1, 2011 (initiated Oct 3, 2011)
StatusTerminated
ReasonThe recall was initiated because Toshiba has confirmed that during patient transfer from a gurney to the catherization table, the tabletop may rotate unexpectedly when sufficient force is applied to the tabletop. The result of the tabletop rotating unexpectedly is the patient being tranferred may fall from the tabletop.
Root causeDevice Design
ActionToshiba America Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated October 3, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers were instructed to follow the user instructions by positioning the tabletop at the foot-end position, and ensuring sufficient assistance is available, when transferring a patient from the gurney to the CAT-850B catheterization table. Customers were also instructed to follow the instructions for transferring a patient to the CAT-850B that are included in the operati
Quantity300 units
DistributionNationwide Distribution.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K081582INFX-8000V, INFINIX-CFI AND INFINIX VFI
Toshiba America Medical Systems, In.C, Jun 17, 2008
K081621INFX-8000C (INFINIX CC-I AND VC-I)
Toshiba America Medical Systems, In.C, Jun 23, 2008
K081624INFX-8000F (INFINIX CSI AND INFINIX DPI)
Toshiba America Medical Systems, In.C, Jun 23, 2008
K082830INFX-8000H, INFINIX-I
Toshiba America Medical Systems, In.C, Oct 10, 2008