510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0925-2015Class II

(R)Cable remote control JUPITER, Material no.1219655, Serial number: to (incl.) 101998119. Patient...

Hill-Rom Inc. / initiated 2014-12-03 / Terminated

Trumpf Medical Systems, Inc. began a recall of (R)Cable remote control JUPITER, Material no.1219655, Serial number: to (incl.) 101998119. Patient positioning during surgery, ranging from anesthesia... 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-0925-2015
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hill-Rom Inc.
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 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
FDA enforcement reports joined to recall event Z-0925-2015
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0918-2015Class IITerminatedVoluntary: Firm initiated
Z-0919-2015Class IITerminatedVoluntary: Firm initiated
Z-0920-2015Class IITerminatedVoluntary: Firm initiated
Z-0921-2015Class IITerminatedVoluntary: Firm initiated
Z-0922-2015Class IITerminatedVoluntary: Firm initiated
Z-0923-2015Class IITerminatedVoluntary: Firm initiated
Z-0924-2015Class IITerminatedVoluntary: Firm initiated
Z-0925-2015Class IITerminatedVoluntary: Firm initiated
Z-0926-2015Class IITerminatedVoluntary: Firm initiated
Z-0927-2015Class IITerminatedVoluntary: Firm initiated
Z-0928-2015Class IITerminatedVoluntary: Firm initiated
Z-0929-2015Class IITerminatedVoluntary: Firm initiated