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U.S. Department of Health and Human Services

Class 3 Device Recall BeneVision Series Telemetry Monitor

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 Class 3 Device Recall BeneVision Series Telemetry Monitorsee related information
Date Initiated by FirmAugust 31, 2026
Date PostedOctober 07, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0111-2027
Recall Event ID 99828
510(K)NumberK242728 
Product Classification System, network and communication, physiological monitors - Product Code MSX
ProductBeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80
Code Information Part numbers of BeneVision Series Telemetry Monitor Operator's Manuals: 1. BeneVision TMS60 (TD60)/TM80 (no alarms) Operator's Manual up to and including revision 5.0; Part No. 046-011232-00 2. BeneVision TM70 Telemetry Monitor Operator's Manual up to and including revision 4.0; Part No. 046-019362-00 3. TM80 Telemetry Monitor Operator's Manual up to and including revision 9.0; Part No. 046-012662-00 4. TMS60 Telemetry Monitoring System Operator's Manual up to and including revision 4.0; Part No. 046-007056-00
FEI Number 2221819
Recalling Firm/
Manufacturer		 Mindray DS USA, Inc.
800 Macarthur Blvd
Mahwah NJ 07430-2001
For Additional Information ContactJames Clifford
+1-201-9958407
Manufacturer Reason
for Recall		Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
FDA Determined
Cause 2		Labeling design
ActionMindray notified consignees on about 08/31/2026 via "URGENT: Medical Device Recall" letter. Consignees were informed that Mindray was providing updated instructions regarding physiological alarms in certain Mindray patient monitoring device Instructions for Use (IFU)/Operator s Manuals. This action is limited to updates to the IFU/Operators Manual content and does not require removal, return, repair, or replacement of the monitors. Consignees were instructed to continue using the Mindray monitors associated with the affected operator s manual, ensure that applicable clinical staff are made aware of the content of this letter and the Operator s Manual Addendum, and if monitors have been distributed or transferred to another organization, please forward this notice to that organization. Additionally, consignees were instructed to complete and return the Acknowledgment and Receipt Form provided. Distributors were instructed to notify their customers. Mindray provided the QR Code for the Operator s Manual Addendum - Addendum of the Arrhythmia Analysis Statement on their portal.
Quantity in Commerce29,737 units
DistributionWorldwide - Nationwide and the country of Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MSX
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