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

Recall Insight

This FDA Devices action (record #Z-2707-2017) was formally reported on July 19, 2017, with the manufacturer initiating the action on March 10, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Merge Healthcare, Inc. is listed as the recalling firm, operating out of Hartland, WI. Federal records indicate 555 PDM's units are affected.

The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: Distribution US nationwide.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 9 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.