Recall Z-0928-2015
Trumpf Medical Systems, Inc. · initiated December 3, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Cable remote control JUC, BUTTON, Material no.1239823, Serial number: to (incl.) 100143048. 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.
Codes / lots: 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.
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: Component change control
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.
Details
- Recall number
- Z-0928-2015
- Initiated
- December 3, 2014
- Posted by FDA
- January 6, 2015
- Terminated
- August 23, 2016
- Product code
- JEA – Table, Surgical With Orthopedic Accessories, Ac-Powered
- Quantity
- 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.
- Recalling firm
- Trumpf Medical Systems, Inc., Charleston, SC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0918-2015 Class II | Cable remote control JUPITER U, Material no.4500119, Serial number: to (incl.)…Complaints have been reported of unintended movement occurring during surgical cases due to the use of… | 12/03/2014Terminated |
| Z-0919-2015 Class II | Cable remote control JUPITER / TS7500, Material no.1601926, Serial number: to (incl.)…Complaints have been reported of unintended movement occurring during surgical cases due to the use of… | 12/03/2014Terminated |
| Z-0920-2015 Class II | Cable remote control JUPITER, Material no. 4544119, Serial number: to (incl.) 102284378.…Complaints have been reported of unintended movement occurring during surgical cases due to the use of… | 12/03/2014Terminated |
| Z-0921-2015 Class II | IR remote control JUPITER U, Material no. 4500120, Serial number: to (incl.) 102306940.…Complaints have been reported of unintended movement occurring during surgical cases due to the use of… | 12/03/2014Terminated |
| Z-0922-2015 Class II | IR remote control JUPITER / TS7500, Material no.1601927, Serial number: to (incl.)…Complaints have been reported of unintended movement occurring during surgical cases due to the use of… | 12/03/2014Terminated |
| Z-0923-2015 Class II | IIR remote control JUPITER, Material no.4544120, Serial number: to (incl.) 102006720.…Complaints have been reported of unintended movement occurring during surgical cases due to the use of… | 12/03/2014Terminated |
| Z-0924-2015 Class II | (R)IR remote control JUPITER, Material no.1219656, Serial number: to (incl.) 102317869.…Complaints have been reported of unintended movement occurring during surgical cases due to the use of… | 12/03/2014Terminated |
| Z-0925-2015 Class II | (R)Cable remote control JUPITER, Material no.1219655, Serial number: to (incl.)…Complaints have been reported of unintended movement occurring during surgical cases due to the use of… | 12/03/2014Terminated |
| Z-0926-2015 Class II | Cable remote control JUX Material, no.1307315, Serial number: to (incl.) 101287649.…Complaints have been reported of unintended movement occurring during surgical cases due to the use of… | 12/03/2014Terminated |
| Z-0927-2015 Class II | IR remote control JUX, Material no.1307314, Serial number: to (incl.) 102338310 Patient…Complaints have been reported of unintended movement occurring during surgical cases due to the use of… | 12/03/2014Terminated |
| Z-0929-2015 Class II | IR remote control JUC, BUTTON, Material no.1239824, Serial number: to (incl.) 100139854.…Complaints have been reported of unintended movement occurring during surgical cases due to the use of… | 12/03/2014Terminated |