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Recall Observatory FDA recall evidence

Device product

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

Z-0040-2017

July 10, 2016

Class II

Product summary

Firm
Trumpf Medical Systems, Inc.
Event
Event 75115
Status
Terminated
Classification
Class II
Quantity
84 units
Official record key
device-enforcement:Z-0040-2017

Official wording

Reason: Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.

Code information: Serial Numbers - 101281354, 101856082, 101858789, 101858794, 101861232, 101871990, 101871991, 101871994, 101871995, 101871998, 101872002, 101872003, 101875823, 101884649, 101884662, 101890660, 101890661, 101890683, 101895634, 101912771, 101912832, 101912833, 101912837, 101912838, 101916174, 101924149, 101863428, 101875818, 101882033, 101882034, 101882037, 101882038, 101901949, 101901951, 101904490, 101904492, 101907204, 101907205, 101909370, 101909371, 101909372, 101909464, 192052657

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.