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-0759-2016Class II

Patient transport Shuttle with Trendelenburg quick adjustment function (Jupiter, Mars, Titan, TruSystem and...

Hill-Rom Inc. / initiated 2016-01-19 / Terminated / root cause: design

Trumpf Medical Systems, Inc. began a recall of Patient transport Shuttle with Trendelenburg quick adjustment function (Jupiter, Mars, Titan, TruSystem and Saturn operating table systems). The shuttle is... on . FDA classified it as Class II and gives the reason as "Complaints were received of the table top on the transporter (shuttle) tilting down quickly in a maximum Trendelenburg position". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0759-2016
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hill-Rom Inc.
Product
Patient transport Shuttle with Trendelenburg quick adjustment function (Jupiter, Mars, Titan, TruSystem and Saturn operating table systems). The shuttle is intended for the following applications: 1. Transfer, transport and storage of exchangeable table tops in the Trumpf Medical TruSystem 7500, JUPITER, and SATURN SM operating table systems 2. Patient transport to an operating table top (without a column) from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system 3. Transporting the TruSystem 7500 SM, JUPITER SM or SATURN SM operating table column with table top (without a patient) within the operating theatre.
Product code
JEA Table, Surgical With Orthopedic Accessories, Ac-Powered
Reason for recall
Complaints were received of the table top on the transporter (shuttle) tilting down quickly in a maximum Trendelenburg position.
Root cause tag
design
FDA root cause
Component design/selection
Action
TRUMPF Medical sent an Urgent Field Safety Information letter dated January 15, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Customers were instructed to take the following actions: Actions to be taken 1. Remove the patient transport Shuttle from operation. 2. Trumpf Medical, or a designated service representative, will schedule an appointment with the customer to perform service on the impacted device to prevent the issue from occurring. Passing along this information: Please make sure that, in your organization, all users of the patient transport Shuttle as well as any other personnel who must be informed, have been made aware of this safety information. If you have provided the device to third parties, please forward them a copy of this letter, or inform the contact person listed above. Please store this information at least until this measure has been completed. If you have any questions concerning this request or the procedure as outlined, please contact Trumpf Medical Systems, Inc. at 888-474-9359 For questions regarding this recall call 843-534-0606.
Quantity in commerce
1284 affected units
Distribution
Worldwide Distribution - US including MA and TX; Foreign distribution to Austria, Azerbaijan, Belgium, British Virgin Islands, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Luxemburg, Morocco, Netherlands, New Caledonia, Norway, Poland, Portugal, Qatar, Romania, San Marino, Spain, Sweden and Switzerland.
Product codes and lots
Product: Shuttle 2.7, Material Number: 1254362, Serial Number Range: 100801175 101349420; Product: Shuttle 2.7 360, Material Number: 1459862, Serial Number Range: 100843669-101212847; Product: Shuttle 3.7, Material Number: 1254363, Serial Number Range: 100180383-101290987 and Product: Shuttle 3.7 360, Material Number: 1459863, Serial Number Range: 100787418-101334652.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0759-2016
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0759-2016Class IITerminatedVoluntary: Firm initiated