Reported Feb 20, 2013 · Terminated
Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and…
Mindray DS USA, Inc. d.b.a. Mindray North America
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mindray DS USA, Inc. d.b.a. Mindray North America · 800 MacArthur Blvd. · Mahwah, NJ · 07430
Is this the product you have?
- Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack
- Part numbers300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Central station and other networked devices
- Lot codes and dates
- Part No Serial NoSoftware Kit
65 of 65 codes
300BF-PA00002EH-17000037300BF-PA00002EH-17000032300BF-PA00002EH-17000033300BF-PA00002EH-25000099300BF-PA00002EH-18000043300BF-PA00003EH-1A000072300BF-PA00002EH-22000088300BF-PA00003EH-1A000073300BF-PA00002EH-12000060300BF-PA00002EH-17000038300BF-PA00003EH-21000077300BF-PA00002EH-18000058300BF-PA00002EH-23000096300BF-PA00003EH-19000059300BF-PA00003EH-19000060300BF-PA00002EH-18000051300BF-PA00002EH-12000054300BF-PA00002EH-16000029300BF-PA00002EH-11000052300BF-PA00002EH-17000039300BF-PA00003EH-1A000064300BF-PA00002EH-18000050300BF-PA00003EH-13000078300BF-PA00003EH-13000085300BF-PA00002EH-18000053300BF-PA00002EH-17000036300BF-PA00002EH-17000031300BF-PA00003EH-17000040300BF-PA00002EH-18000054300BF-PA00002EH-1A000069
Software Kit 115-006908-03 Software Kit 115-006908-03 Software Kit300BF-PA00003EH-13000083300BF-PA00003EH-13000084300BF-PA00003EH-22000087300BF-PA00002EH-18000056300BF-PA00002EH-17000035300BF-PA00002EH-18000048300BF-PA00002EH-18000052300BF-PA00003EH-21000081300BF-PA00002EH-17000030115-006908-03
300BF-PA00003EH-19000062300BF-PA00002EH-18000057300BF-PA00003EH-22000083300BF-PA00002EH-11000051300BF-PA00002EH-18000041300BF-PA00002EH-21000082.
- Part No Serial No
- Amount recalled
- 51 units
Where it was sold
- Nationwide
Why it was recalled
Mindray has identified a software anomaly that may where, in the presence of an asystole, the Telepack ECG waveform may produce a unique step pattern (instead of a flat line) if Lead 1 or V is being utilized for detecting cardiac arrhythmia.
This product could cause temporary or reversible health problems — stop using it.
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