Stryker Renaissance Series/Advantage Series PACU wheeled stretcher, Model 1501, Stryker Medical, Portage, MI 49002

FDA device recall Z-0235-2008 · posted 2007-11-10 · Terminated

Recall details

Recalling firm

Stryker Medical Div. of Stryker Corporation

Reason for recall

The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.

Action taken

The firm issued an Urgent Medical Device Correction Letter dated 9/24/07, to each consignee informing them of the problems, that the brakes on each affected stretcher needed to be inspected/tested and removed from service if brake problems were discovered, and that a Stryker service representative would be in contact to replace the brakes.

Root cause

Component change control

Status

Terminated

Product code

FPO

Quantity affected

81,367 (61,708 U.S. and 19,569 ex-U.S.) for all models.

Distribution

Worldwide-USA, Argentina, Australia, Brazil, Canada, Chile, China, Dubai, France, India, Italy, Japan, Germany, Greece, Hong Kong, Korea, Latin America, Malaysia, Mexico, Netherlands, Poland, Portugal

Date initiated

2004-11-15

Date posted

2007-11-10

Date terminated

2010-10-27

Location

Portage, MI