Z-2707-2017Class II

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

Name: Z-2707-2017 The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo...
Creator: Merge Healthcare, Inc.
Published: 2016-03-10
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2016-03-10 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software on 2016-03-10. FDA classified it as Class II and gives the reason as "If the PDM is utilized to output a pressure for computing fractional flow reserve (FFR), the analog output may not reflect the true representation of the selected pressure waveform being provided by the PDM to the Link...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2707-2017
Classification: Class II
Status: Terminated
Initiated: 2016-03-10
Posted: 2017-07-10
Terminated: 2020-03-06
Recalling firm: Merge Healthcare Incorporated
Product: The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: If the PDM is utilized to output a pressure for computing fractional flow reserve (FFR), the analog output may not reflect the true representation of the selected pressure waveform being provided by the PDM to the Link Assembly which provides the analog output.
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm issued recall letters dated 3/10/2016, 5/3/2016, and 8/5/2016 via email or via certified mail if the email address is not available.
Quantity in commerce: 555 PDM's
Distribution: Distribution US nationwide.
Product codes and lots: All Schiller PB-1000 PDM's distributed on or before 8/11/2016.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2707-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2707-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-10

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)