[pending] Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/Catalo
Pending LLM rewrite. Source: FDA_DEVICE Z-1201-2026.
What this means for you
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: Pending LLM scoring against the rubric.
Plain-English summary
Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.
The recalled product
- Product
- Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/Catalog Number: 60500010100 Software Version: Software version v2.04 or prior are within scope of the recall for A.T.S.¿ 5000TS Product Description: A.T.S 5000TS Tourniquet Systems Co
- Manufacturer
- Zimmer Surgical Inc
- Category
- Medical Device — Devices
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 (20)
- Lot Code: Model No. 60500010100
- UDI (01)00889024626454(11)240410(10)66722609(21)50066722609001
- Lot No. 66722609
- Serial No. 50066722609001 Model No. 60500010100
- UDI "(01)00889024626454(11)240410(10)66722609(21)50066722609002
- Serial No. 50066722609002 Model No. 60500010100
- UDI "(01)00889024626454(11)240410(10)66722609(21)50066722609003"
- Serial No. 50066722609003 Model No. 60500010100
- UDI "(01)00889024626454(11)240410(10)66722609(21)50066722609004"
- Serial No. 50066722609004 Model No. 60500010100
- UDI "(01)00889024626454(11)240410(10)66722609(21)50066722609005"
- Serial No. 50066722609005 Model No. 60500010100
- UDI "(01)00889024626454(11)240410(10)66722610(21)50066722610001"
- Lot No. 66722610
- Serial No. 50066722610001 Model No. 60500010100
- UDI "(01)00889024626454(11)240410(10)66722610(21)50066722610002"
- Serial No. 50066722610002 Model No. 60500010100
- UDI "(01)00889024626454(11)240410(10)66722610(21)50066722610003"
- Serial No. 50066722610003 Model No. 60500010100
- UDI "(01)00889024626454(11)240410(10)66722610(21)50066722610004"
Distribution
Distribution scope not specified by the agency.
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