Model CAT-850B Catheterization Table, a component of the Toshiba INFX-8000 series X-Ray Interventional System. These sys

FDA device recall Z-0331-2012 · posted 2011-12-01 · Terminated

Recall details

Recalling firm

Toshiba American Medical Systems Inc

Reason for recall

The 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.

Action taken

Toshiba 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 operation manual. A Customer Reply Form was included with the letter for customers to complete and return via fax to (877) 349-3054. The customer reply form can also be sent via e-mail to raffairs@tams.com. Questions regarding the recall letter can contact the Director of Regulatory Affairs at (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968.

Root cause

Device Design

Status

Terminated

Product code

MQB

Quantity affected

300 units

Distribution

Nationwide Distribution.

Date initiated

2011-10-03

Date posted

2011-12-01

Date terminated

2013-03-18

Location

Tustin, CA

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