CLASS II Device recall · Reported 27 Nov 2013 · FDA Enforcement Report
TruSystem Surgical Table (TS7000) Leg Section One Part recalled
Trumpf Medical Systems is recalling TruSystem Surgical Table (TS7000) Leg Section One Part Light HU Use of the Leg Section, distributed in 8 states. The recall was initiated on 28 Oct 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0342-2014
- FDA event ID
- 66688
- Recalling firm
- Trumpf Medical Systems, Charleston, SC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Oct 2013
- FDA classified
- 18 Nov 2013
- Reported
- 27 Nov 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 28 Oct 2013 | Recall initiated by company | |
| 18 Nov 2013 | Classified by FDA | +21 days |
| 27 Nov 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The coupler point (hood) of the Leg Section One Part Light may become detached from the leg section frame.
Product as listed by the FDA
TruSystem Surgical Table (TS7000) Leg Section One Part Light HU Use of the Leg Section One Part Light HU is permitted only with the TRUMPF TruSystem 7000 operating table. The operating table TruSystem 7000, in conjunction with operating table components is intended for the use of patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. The Leg Section One Part Light HU is attached to coupling point L on the operating table and is used to position the patients legs during pre-op and post-op surgery.
Where it was distributed
US Distribution including the states of CA, IL, NJ, NY, NC, TX, WA and SC.
CaliforniaIllinoisNorth CarolinaNew JerseyNew YorkSouth CarolinaTexasWashington
Questions about this recall
Why was it recalled?
The coupler point (hood) of the Leg Section One Part Light may become detached from the leg section frame.
Which lots are affected?
Item no. 1739993, All serial numbers.
Where was it sold?
US Distribution including the states of CA, IL, NJ, NY, NC, TX, WA and SC.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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