Z-0923-2015Class II
IIR remote control JUPITER, Material no.4544120, Serial number: to (incl.) 102006720. Patient positioning...
Hill-Rom Inc. / initiated 2014-12-03 / Terminated
Trumpf Medical Systems, Inc. began a recall of IIR remote control JUPITER, Material no.4544120, Serial number: to (incl.) 102006720. Patient positioning during surgery, ranging from anesthesia induction to... on . FDA classified it as Class II and gives the reason as "Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0923-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Hill-Rom Inc.
- 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 code
- JEA Table, Surgical With Orthopedic Accessories, Ac-Powered
- Reason for recall
- Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
- FDA root cause
- Component change control
- Action
- 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.
- Quantity in commerce
- 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.
- Product codes and 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.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0918-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0919-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0920-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0921-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0922-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0923-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0924-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0925-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0926-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0927-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0928-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0929-2015 | Class II | Terminated | Voluntary: Firm initiated |
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