Recall record at a glance
| Official record | Z-0391-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Trumpf Medical Systems, Inc. |
| Report date | Nov 16, 2016 |
| Recall initiation date | Oct 25, 2016 |
| Quantity | 4 (US) & 229 (Foreign) |
| Location | Charleston, SC, United States |
Official 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.
Why the product was recalled
Trumpf has identified six incidents of pinched cables.
Distribution information
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
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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