Trumpf Medical Systems Recalls JUPITER Remote Controls Due to Unintended Movement
Trumpf Medical Systems is recalling JUPITER remote controls for operating tables because damaged units may cause unintended movement during surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 IR remote control JUPITER / TS7500 (Material no. 1601927, Serial number to 102222333). The recall involves 3,303 total devices distributed worldwide, including in the United States and Canada.
The recall was initiated after complaints were reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes. These remote controls are used for patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia, as well as for patient transport on the operating tabletop.
The affected remote controls are used with specific operating table columns and tables, including the Mobile column JUPITER System U, Mobile column JUPITER System Miyabi U, and Operating table column JUPITER SM 360 U. Users should contact the manufacturer for further instructions on how to address the issue.
The recalled product
- Product
- IR remote control JUPITER / TS7500, Material no.1601927, Serial number: to (incl.) 102222333. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient…
- 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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