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 Component: N/A
FDA Recall Z-1201-2026 · Posted 2026-01-28
Advertisement
Recalling FirmZimmer Surgical Inc
Recall StatusOpen, Classified
Product CodeKCY
Date Initiated2025-12-24
Product Quantity206
Reason for Recall
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.
Firm Action
On December 30, 2025, the firm began notifying consignees through Urgent Medical Device Recall letters.
The firm is conducting this recall in two phases. In Phase 1, which began on 12/30/2025, consignees are informed that the screen may freeze or stop responding to touch when used in certain international languages. Users may continue to use the device by utilizing the English language mode. Use of the device in an affected language is not advised, and may cause the issue to occur.
ATS5000 Affected Languages:
Czech, Danish, Finnish, French, Italian, Lithuanian, Norwegian, Romanian, Slovak, Slovenian, and Turkish
Unaffected Languages:
English, Chinese (simplified), Korean, Japanese, Greek, Bulgarian, and Russian
All devices manufactured between April 2024 - September 2025 with software version v2.04 are within scope of the recall. Affected devices will require an upgrade to the new software version v2.05 when it is available in early 2026.
The firm will issue a removal notice (Phase 2) once the new software version is available. Customers are instructed to not return affected devices before the initiation of Phase 2.
Root Cause
Under Investigation by firm
Distribution Pattern
International distribution to the countries of Canada and EMEA only.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement