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Terminated

Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5500, Material Number 1607822 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

FDA Recall Z-0040-2017 · Posted 2016-10-05

Recalling FirmTrumpf Medical Systems, Inc.
Recall StatusTerminated
Product CodeJEA
Date Initiated2016-07-10
Date Terminated2017-03-02
Product Quantity84 units

Reason for Recall

Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.

Firm Action

Trumpf Medical sent an Urgent Field Safety Notice dated July 8, 2015, to all affected consignees. The letter indicated that the tables should not be used until an authorized service engineer has exchanged the spindles of the affected operating tables. The letter included an acknowledgement form which is to be returned. The letter also requested a sub-recall if the product had been further distributed. For questions regarding this recall call 843-329-0543.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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