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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75616

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

Open FDA event record

Event summary

Timeline bucket
May 31, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Merge Healthcare, Inc.

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

The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.

Z-1203-2017
Recall number
Z-1203-2017
Initiated
May 31, 2015
Classification
Class II
Status
Terminated
Recalling firm
Merge Healthcare, Inc.
Quantity
341 sites potentially have the affected product versions

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to fail prior to reaching adequate initial pressure.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to fail prior to reaching adequate initial pressure.

Code information

Patient Data Module (PDM) V2 model: Serial numbers 10.03.XXXXX

Distribution pattern

Distribution was nationwide to medical facilities. There was also military and government distribution.