Merge Healthcare, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1203-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 31, 2015

Date Posted: February 22, 2017

Recall Number: Z-1203-2017

Event ID: 75616

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.

Status: Terminated

Product Quantity: 341 sites potentially have the affected product versions

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.

Voluntary or Mandated:

Voluntary: Firm initiated