Trumpf Medical Systems, Inc.: Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes

Agency Publication Date: January 6, 2015

Affected Products

Product: Cable remote control JUPITER U, Material no.4500119, Serial number: to (incl.) 102306915. 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.

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.

Product: Cable remote control JUPITER / TS7500, Material no.1601926, Serial number: to (incl.) 101465919. 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.

Product: Cable remote control JUPITER, Material no. 4544119, Serial number: to (incl.) 102284378. 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.

Product: IR remote control JUPITER U, Material no. 4500120, Serial number: to (incl.) 102306940. 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.

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 transfer system to the operating theatre or from the operating theatre to the patient transfer system.

Product: IIR remote control JUPITER, Material no.4544120, Serial number: to (incl.) 102006720. 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.

Product: (R)IR remote control JUPITER, Material no.1219656, Serial number: to (incl.) 102317869. 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.

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.

Product: Cable remote control JUX Material, no.1307315, Serial number: to (incl.) 101287649. 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.

Product: IR remote control JUX, Material no.1307314, Serial number: to (incl.) 102338310 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.

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.

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.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 69927

Status: Resolved

Manufacturer: Trumpf Medical Systems, Inc.

Manufactured In: United States

Units Affected: 12 products (137 units; 3303 total all devices; 3303 total all devices; 3303 total all devices; 3303 total all devices; 3303 total all devices; 3303 total all devices; 3303 total all devices; 3303 total all devices; 3303 total all devices; 3303 total all devices; 3303 total all devices)

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Sources: FDA iRES · Raw API Response

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