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Recall Observatory FDA recall evidence

Device product

Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia detection, ST Segment analysis, and heart rate.

Z-2737-2015

July 27, 2015

Class II

Product summary

Firm
Mindray DS USA, Inc. dba Mindray North America
Event
Event 71934
Status
Terminated
Classification
Class II
Quantity
13 units
Official record key
device-enforcement:Z-2737-2015

Official wording

Reason: The DPM 7 Monitors may display a black screen.

Code information: Lot #14A18, PN: 6800F-PA00001, Serial Numbers: DU- 46002583, DU-46002587, DU-46002588, DU-46002589, DU-46002592, DU-46002594, DU-46002595, DU-46002596, DU-46002599, DU-46002600, DU-46002601, DU-46002605 and DU-46002606

Distribution pattern: Distributed to the states of CT, IA, KY, MS, PA, UT and WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The DPM 7 Monitors may display a black screen.