Z-0391-2017 Class II Terminated
FDA device recall Z-0391-2017 was initiated by Trumpf Medical Systems, Inc. on October 25, 2016 and is designated Class II. Reason for recall: Trumpf has identified six incidents of pinched cables. The recall status is terminated (terminated February 6, 2017). Affected quantity: 4 (US) & 229 (Foreign).
Recall Details
- Product Type
- Devices
- Report Date
- November 16, 2016
- Initiation Date
- October 25, 2016
- Termination Date
- February 6, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 (US) & 229 (Foreign)
Product Description
OR 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.
Reason for Recall
Trumpf has identified six incidents of pinched cables.
Distribution Pattern
Worldwide 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
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