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

Recall number

Z-1203-2017

Recalling firm

Merge Healthcare, Inc.

Product

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

Status

Terminated

Initiated

2015-05-31

Posted

not on file

Terminated

2020-03-13

Reason

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

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

341 sites potentially have the affected product versions

Distribution

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

Lot, serial or model codes

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

510(k) numbers

["K082421"]

PMA numbers

not on file

Product code

DQK

Firm FEI

1000116130

Firm city

Hartland

Firm state

WI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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