Device product
(R)Cable remote control JUPITER, Material no.1219655, Serial number: to (incl.) 101998119. 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.
Z-0925-2015
Product summary
- Event
- Event 69927
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3303 total all devices
- Official record key
device-enforcement:Z-0925-2015
Official wording
Reason: Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
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.
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.
Derived failure modes
-
Unknown
Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes