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U.S. Department of Health and Human Services

Class 2 Device Recall Operating Table TruSystem 7000 U

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 Class 2 Device Recall Operating Table TruSystem 7000 Usee related information
Date Initiated by FirmJuly 10, 2016
Date PostedOctober 05, 2016
Recall Status1 Terminated 3 on March 02, 2017
Recall NumberZ-0043-2017
Recall Event ID 75115
Product Classification Table, surgical with orthopedic accessories, ac-powered - Product Code JEA
ProductOperating 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
Code Information Serial Numbers - 101863316, 101872464, 101879109, 101880571, 101880672, 101880673, 101928935, 101932527, 101937343, 101941055, 101941064, 101941995, 101942798, 101948309, 101954296, 102051758, 102061764, 101926753, 101928934, 101941978, 101941994
Recalling Firm/
Manufacturer		 Trumpf Medical Systems, Inc.
1046 Legrand Blvd
Charleston SC 29492-7672
For Additional Information ContactChandler Sprinkles
843-329-0543
Manufacturer Reason
for Recall		Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionTrumpf 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.
Quantity in Commerce84 units
DistributionWorldwide 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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