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
Product summary
- 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
Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.