Z-1203-2017Class II

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

Name: Z-1203-2017 The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the...
Creator: Merge Healthcare, Inc.
Published: 2015-05-31
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2015-05-31 / Terminated / root cause: manufacturing process

FDA source

Merge Healthcare, Inc. began a recall of The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software on 2015-05-31. FDA classified it as Class II and gives the reason as "Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to fail prior to reaching adequate initial pressure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1203-2017
Classification: Class II
Status: Terminated
Initiated: 2015-05-31
Posted: 2017-02-15
Terminated: 2020-03-13
Recalling firm: Merge Healthcare Incorporated
Product: The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.
Product code: DQK Computer, Diagnostic, Programmable
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recalling firm issued letters via email dated 3/28/2016 and 7/11/2016, or via certified mail if no email address was available. A third letter dated 1/23/2017 was also issued..
Quantity in commerce: 341 sites potentially have the affected product versions
Distribution: Distribution was nationwide to medical facilities. There was also military and government distribution.
Product codes and lots: Patient Data Module (PDM) V2 model: Serial numbers 10.03.XXXXX

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1203-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1203-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-22	2017-02-15

Product code DQK

K082421Class IIHeartsuite Hemodynamics 7.10Emageon, Inc. / cleared 2008-12-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)