A.T.S. 3200TS tourniquets recalled over screens that may freeze
Zimmer Surgical is recalling 51 A.T.S. 3200TS Tourniquet Systems because the user interface may freeze or become unresponsive to touch in certain non-English language settings.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record's stated consequence is a delay while an alternate device is located, with no patient harm or reported injury.
Plain-English summary
Zimmer Tourniquet Systems A.T.S. 3200TS Tourniquet Systems, model/catalog number 60320010100, are being recalled by Zimmer Surgical Inc. The record states software version v2.06 or prior is within the scope of the recall.
The reason given in the enforcement record is that the device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. The record states the issue may cause delay or extension while an alternate device is located.
The record lists 51 units under model 60320010100, with UDI, lot and serial numbers recorded in the enforcement record. Distribution was international, to Canada and EMEA only. The FDA has classified the action as Class II.
The stated consequence in the enforcement record is a delay or extension while an alternate device is located, and no injuries are reported. Facilities should follow Zimmer's instructions.
The recalled product
- Product
- Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tourniquet Systems Model/Catalog Number: 60320010100 Software Version: Software version v2.06 or prior are within scope of the recall for A.T.S.¿ 3200TS Product Description: A.T.S 3200TS Tourniquet Systems…
- Manufacturer
- Zimmer Surgical Inc
- Category
- Medical Device — Tourniquet
- Affected units
- 51
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. 60320010100
- UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739001"
- Lot No. 67505739
- Serial No. 32067505739001 Model No. 60320010100
- UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739003"
- Serial No. 32067505739003 Model No. 60320010100
- UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739004"
- Serial No. 32067505739004 Model No. 60320010100
- UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739005"
- Serial No. 32067505739005 Model No. 60320010100
- UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739006"
- Serial No. 32067505739006 Model No. 60320010100
- UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739007"
- Serial No. 32067505739007 Model No. 60320010100
- UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739008"
- Serial No. 32067505739008 Model No. 60320010100
- UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739010"
- Serial No. 32067505739010 Model No. 60320010100
- UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739013"
- Serial No. 32067505739013 Model No. 60320010100
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Zimmer Surgical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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