Z-0155-2014Class III
ORBIT PT. The ORBIT PT works in conjunction with an TRUMPF mobile operating table to automate the patient...
Hill-Rom Inc. / initiated 2013-07-24 / Terminated / root cause: design
Trumpf Medical Systems began a recall of ORBIT PT. The ORBIT PT works in conjunction with an TRUMPF mobile operating table to automate the patient transport process on . FDA classified it as Class III and gives the reason as "An odor and smoke developed - The cause was determined to be a power supply unit sitting in the controller column". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-0155-2014
- Classification
- Class III
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Hill-Rom Inc.
- Product
- ORBIT PT. The ORBIT PT works in conjunction with an TRUMPF mobile operating table to automate the patient transport process.
- Product code
- JEA Table, Surgical With Orthopedic Accessories, Ac-Powered
- Reason for recall
- An odor and smoke developed - The cause was determined to be a power supply unit sitting in the controller column.
- Root cause tag
- design
- FDA root cause
- Component design/selection
- Action
- The user facility was contacted via phone in early August. They were contacted 9/17/2013 to schedule the replacement of the power pack because the new power pack became available.
- Quantity in commerce
- One
- Distribution
- US Distribution: NJ only.
- Product codes and lots
- Item No. 1275499, Serial No. 100711351
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0155-2014 | Class III | Terminated | Voluntary: Firm initiated |
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