Trumpf Medical Systems Recalls Operating Room Table Tops for Cable Pinching
Trumpf Medical Systems is recalling specific operating room table tops after identifying six incidents of pinched cables.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a mechanical defect (pinched cables) that poses a risk of harm to patients, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Trumpf Medical Systems, Inc. is recalling specific operating room (OR) table tops, including models U26 H V, U26 H V U, U24 H V, U24 H V U, U24 H V W, and U14 H V. The recall covers 4 units in the United States and 229 units in foreign countries. The affected products are used for patient positioning during surgery and patient transport.
The recall was initiated because the manufacturer identified six incidents of pinched cables associated with these table tops. The affected units were distributed worldwide, including in the US states of Arizona and South Carolina, as well as in Australia, Austria, Belgium, China, the Czech Republic, Denmark, Finland, France, Germany, Great Britain, Iceland, Italy, Norway, Qatar, Slovenia, Spain, Sweden, and Switzerland.
Healthcare facilities should stop using the affected table tops and contact Trumpf Medical Systems for further instructions on the recall.
The recalled product
- Product
- 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…
- Manufacturer
- Trumpf Medical Systems, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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
Distribution
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