(R)IR remote control JUPITER, Material no.1219656, Serial number: to (incl.) 102317869. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
FDA Recall Z-0924-2015 · Posted 2015-01-06
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Recalling FirmTrumpf Medical Systems, Inc.
Recall StatusTerminated
Product CodeJEA
Date Initiated2014-12-03
Date Terminated2016-08-23
Product Quantity3303 total all devices
Reason for Recall
Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
Firm Action
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
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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