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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63800

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
September 05, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Mindray DS USA, Inc. d.b.a. Mindray North America

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.

Z-0742-2013
Recall number
Z-0742-2013
Initiated
September 05, 2012
Classification
Class II
Status
Terminated
Quantity
13 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available.

Code information

p/n 9201F-PA000XX DS- 0C000565 02000335 12000603 12000599 12000597 OCOOO569 9A000247 9A000252 17000648 06000490 05000470 05000466 02000373

Distribution pattern

US Nationwide Distribution including the states of: VA, TN, FL, & TX