Trumpf Medical Systems Recalls JUPITER Remote Controls for Unintended Movement
Trumpf Medical Systems is recalling JUPITER remote controls used with operating tables due to reports of unintended movement during surgical cases.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used during surgery where unintended movement poses a risk of harm to patients, but the source text does not report specific injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Trumpf Medical Systems, Inc. is recalling the (R)Cable remote control JUPITER (Material no. 1219655, serial numbers up to and including 101998119). These remote controls are used to position patients during surgery, ranging from anesthesia induction to recovery, and for patient transport on operating tabletops.
The recall is being conducted because complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes. The affected remote controls are used with various JUPITER operating table columns and tables, including the Mobile column JUPITER System U, Operating table JUPITER UNIVERSAL U, and OR-TABLE JUPITER UNIVERSAL CARBON U.
A total of 3,303 devices are affected. The products were distributed worldwide, including in the United States (specifically 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, and WI) and internationally to Canada. Healthcare facilities should stop using the affected remote controls and contact the manufacturer for instructions on repair or replacement.
The recalled product
- 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
- Manufacturer
- Trumpf Medical Systems, Inc.
- Affected units
- 3,303
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- 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
Part of a larger recall action
This product is one of 12 recalled by Trumpf Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
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