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U.S. Department of Health and Human Services

Class 2 Device Recall JUPITER

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  Class 2 Device Recall JUPITER see related information
Date Initiated by Firm December 03, 2014
Date Posted January 06, 2015
Recall Status1 Terminated 3 on August 23, 2016
Recall Number Z-0929-2015
Recall Event ID 69927
Product Classification Table, surgical with orthopedic accessories, ac-powered - Product Code JEA
Product IR remote control JUC, BUTTON, Material no.1239824, Serial number: to (incl.) 100139854.
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.
Code Information The operating tables which are operated with the affected remote controls (all serial numbers): Mobile column JUPITER System U, Material no. 4500113; Mobile column JUPITER System Miyabi U, Material no. 1574977; Operating table column JUPITER SM 360 U, Material no. 1389824; Operating table column JUPITER SF U OCE, Material no. 1622774; Stationary column JUPITER System U, Material no. 4500112; FLOOR MOUNTING COLUMN JUPITER U, Material no. 1276277; Floor mounting column JUPITER 360 U, Material no.1389826; Operating table JUPITER UNIVERSAL U, Material no. 4500170; OR-TABLE JUPITER UNIVERSAL CARBON U, Material no.1223188.
Recalling Firm/
Manufacturer		 Trumpf Medical Systems, Inc.
1046 Legrand Blvd
Charleston SC 29492-7672
For Additional Information Contact Lindsey Ronnenberg
843-534-0606
Manufacturer Reason
for Recall		 Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
FDA Determined
Cause 2		 Component change control
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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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