FDA Enforcement Class II Terminated

SHAPE ARM, DUAL SH2, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682400254 and the Arm part number in the kit is P17084 . The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.

Recall: Z-2053-2014 · Reported July 23, 2014

Enforcement

Recall Number
Z-2053-2014
Event ID
67813
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Stryker Communications
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
July 23, 2014
Initiation Date
March 17, 2014
Classification Date
July 15, 2014
Termination Date
May 15, 2015
Address
1410 Lakeside Pkwy Ste 100, N/A, Flower Mound, TX, 75028-4026, United States

Description

SHAPE ARM, DUAL SH2, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682400254 and the Arm part number in the kit is P17084 . The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.

Reason

During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present.

Code Info

Serial numbers 111018DF001 through 120409DF045 Serial and part numbers are located on underside of the cover of the portion of the Arm that is attached to the boom's service head. Screws must be removed and the cover detached to view these numbers.

Distribution

Worldwide Distribution. US nationwide including Puerto Rico, China, Philippines, Mexico, Korea, Japan, Colombia, Chile, Canada, Brazil, and Australia

Quantity

953 total STRYKER SHAPE Arms of all types