IR remote control JUPITER U, Material no. 4500120, Serial number: to (incl.) 102306940. Patient positioning during surge

FDA device recall Z-0921-2015 · posted 2015-01-06 · Terminated

Recall details

Recalling firm

Trumpf Medical Systems, Inc.

Reason for recall

Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes

Action taken

Trumpf sent an Urgent Medical Device Correction letter on December 3, 2014, to all affected customers. Customers were instructed to complete and return the Confirmation of Receipt form with serial numbers of the affected table(s) and the serial number(s) for any remote controls they have. Replacement remotes will be sent. Customers were instructed to dispose of their recalled remotes. Customers with questions were instructed to call 888-474-9359. For questions regarding this recall call 843-534-0606.

Root cause

Component change control

Status

Terminated

Product code

JEA

Quantity affected

3303 total all devices

Distribution

Worldwide Distribution - USA including AL, AZ, CA, CT, FL, GA, IL, KS, LA, MD, MI, MK, MS, NC, NH, NJ, NY, OH, OK, PA, RI, SC, TX, VA, WA, WI and Internationally to Canada.

Date initiated

2014-12-03

Date posted

2015-01-06

Date terminated

2016-08-23

Location

Charleston, SC