Z-0040-2017 Class II Terminated
FDA device recall Z-0040-2017 was initiated by Trumpf Medical Systems, Inc. on July 10, 2016 and is designated Class II. Reason for recall: Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters. The recall status is terminated (terminated March 2, 2017). Affected quantity: 84 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 12, 2016
- Initiation Date
- July 10, 2016
- Termination Date
- March 2, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 84 units
Product Description
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
Reason for Recall
Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.
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
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