CLASS II Device recall · Reported 12 Oct 2016 · FDA Enforcement Report
Operating Table TruSystem 7000 U, Material Number recalled
Trumpf Medical Systems is recalling Operating Table TruSystem 7000 U, Material Number 1604788, distributed nationwide in the US. The recall was initiated on 10 Jul 2016 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-0043-2017
- FDA event ID
- 75115
- Recalling firm
- Trumpf Medical Systems, Charleston, SC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jul 2016
- FDA classified
- 5 Oct 2016
- Reported
- 12 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 10 Jul 2016 | Recall initiated by company | |
| 5 Oct 2016 | Classified by FDA | +87 days |
| 12 Oct 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.
Product as listed by the FDA
Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), Material Number 1604786 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system
Where it was distributed
Worldwide Distribution - US including CA, CT, GA, IL, NC, OR, SC, VA, WI, WY, and Internationally to Australia, Azerbaijan, Brazil, Finland, France, Germany, Hungary, Italy, Luxembourg, Norway, Poland, Russia, Slovakia, and Switzerland
Nationwide CaliforniaConnecticutGeorgiaIllinoisNorth CarolinaOregonSouth CarolinaVirginiaWisconsinWyoming
Questions about this recall
Is Operating Table TruSystem 7000 U, Material Number 1604788 recalled?
Yes. Trumpf Medical Systems recalled Operating Table TruSystem 7000 U, Material Number 1604788 on 10 Jul 2016. The recall is Class II and its status is Terminated. Recall number Z-0043-2017.
Why was it recalled?
Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.
Which lots are affected?
Serial Numbers - 101863316, 101872464, 101879109, 101880571, 101880672, 101880673, 101928935, 101932527, 101937343, 101941055, 101941064, 101941995, 101942798, 101948309, 101954296, 102051758, 102061764, 101926753, 101928934, 101941978, 101941994
Where was it sold?
Worldwide Distribution - US including CA, CT, GA, IL, NC, OR, SC, VA, WI, WY, and Internationally to Australia, Azerbaijan, Brazil, Finland, France, Germany, Hungary, Italy, Luxembourg, Norway, Poland, Russia, Slovakia, and Switzerland
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 21 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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