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Recall Observatory FDA recall evidence

Derived label

Device software or design

Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)], 00-1004 00-1004 [Tempus Pro (IB Only)]

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
software issue that causes an error
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Remote Diagnostic Technologies Ltd.

Field note

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