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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:154942

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

Official recall number

Z-2707-2017

Evidence summary

Product code
DQK
Recall status
Terminated
Event initiated
March 10, 2016
Root cause
Software design
Source snapshot
d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product
Z-2707-2017

Field note

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