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U.S. Department of Health and Human Services

Class 2 Device Recall OR Table, Top

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 Class 2 Device Recall OR Table, Topsee related information
Date Initiated by FirmOctober 25, 2016
Date PostedNovember 10, 2016
Recall Status1 Terminated 3 on February 06, 2017
Recall NumberZ-0391-2017
Recall Event ID 75412
Product Classification Table, surgical with orthopedic accessories, ac-powered - Product Code JEA
ProductOR Table, Top U26 H V, Model # 1909793; OR Table Top U26 H V U, Model # 1909794; OR Table Top U24 H V, Model # 1909796; OR Table Top U24 H V U, Model # 1909797; OR Table Top U24 H V W, Model # 1909798; OR Table Top U14 H V, Model # 1909799 Product Usage: Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Patient transport on the operating table top from a patient transfer system to the operating theater or from the operating theater to a patient transfer system.
Code Information Model # 190973 - Serial Number Range 102394262 - 102974610; Model # 1909794 - 102884276; Model # 1909796 - 102440024 - 102981676; Model # 1909797 - 102757564 - 102958935; Model # 1909798 - 102831498 - 102831519; Model # 1909799 - 102393683 - 102969656
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		Trumpf has identified six incidents of pinched cables.
FDA Determined
Cause 2		Process control
ActionTrumpf Medical sent an Urgent Medical Device Correction letter dated October 7, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken The letter indicated that a authorized service provider will inspect the table tops and make necessary corrections. A confirmation notice was included with the letter which is to be returned. For contact Trupmpf Medical Systems, Inc. at 888-474-9359.
Quantity in Commerce4 (US) & 229 (Foreign)
DistributionWorldwide Distribution - US Nationwide in the states of AZ and SC and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Iceland, Italy, Norway, Qatar, Slovenia, Spain, Sweden, 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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