Recall Z-2055-2014 ยท BRY Cabinet, Table And Tray, Anesthesia
Stryker Communications
BAM (SHAPE) ARM, LEFT, 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 component of kit part number 0682000976, and the Arm part number in the kit is P17087. The kit, when assembled, supports a flat-panel video monitor that is attached to one o
| Date | Jul 15, 2014 (initiated Mar 17, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | Direct accounts in the US were notified by letter dated March 21, 2014, and asked to report any malfunctions to Stryker Communications immediately. In addition, Stryker Representatives will visit all US accounts to inspect all the product units on hand. If needed, Representatives will check that black, screw/lock washers supplied by Stryker are secured in place and will replace any that are not the typed furnished by Stryker. All units will be updated with a yellow, warning sticker on the monitor bracket which reads: "Failure to properly install the screw and lock washer below can result i |
| Quantity | 953 SHAPE Arms of all types |
| Distribution | Worldwide Distribution. US nationwide including Puerto Rico, China, Philippines, Mexico, Korea, Japan, Colombia, Chile, Canada, Brazil, and Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.