SmartMonitor 2PSL Hospital Alarm w/ Modem 1038140Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B0361038140), received between Nov 16, 2018 and Nov 16, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Solder Joint Fracture” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K061256); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 2018Solder Joint Fracture; Solder Joint Fracture

  A USER FACILITY REPORTED THAT THE NURSE CALL JACK ON THE MONITOR WAS NOT OPERATING PROPERLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8080927 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061256. One submission often covers many models, so check the product and lot details in each record.

• Z-2250-2017 · May 1, 2017 · Terminated
  SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients.
• Z-1789-2014 · Apr 29, 2014 · Terminated
  Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.
• Z-1086-2008 · Oct 15, 2007 · Terminated
  APNEA monitor accessories under the following brand names: a) SM 2 PS/PSL, Prof. Operators Manual, NL-NL model number 1025422; b) SM 2/2 PS Europe Patient Cable, Metal model number