The Recall Desk
ModerateFDA (Devices)·Z-1789-2014·Announced 2014-06-25

Philips Smart Monitor 2 Professional Series Infant Apnea Monitor Recall

Children's Medical Ventures is recalling 112 infant apnea monitors due to a battery wire harness defect that renders the devices inoperable.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the defect renders the device inoperable without reports of injury or death, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Children's Medical Ventures is recalling 112 units of the Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor. The recall is due to an improperly assembled battery pack wire harness that causes the device to display an error code and sound an alarm repeatedly at power up. This defect renders the device inoperable until the issue is addressed.

The affected units were distributed worldwide, including in the United States (specifically MI, WI, SC, FL, TX, KS, MA, AZ, UT, WV, IN, MN, NV, and VA) and in Australia, Belgium, and Canada. The recall number is Z-1789-2014.

Consumers should stop using the affected monitors and contact Children's Medical Ventures for instructions on how to address the defect. The specific serial numbers and lot codes for the affected units are listed in the official recall documentation.

The recalled product

Product
Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.
Affected units
112

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

  • 989805603611 / 1014557
  • 989805603631 / 1014559
  • 989805604511 / 1028969
  • 989805604521 / 1028970
  • 989805604531 / 1028971
  • 989805604631 / 1030271
  • 989805605051 / 1038140
  • 989805605061 / 1038141
  • 989805608801 / U1014557
  • 989805608811 / U1014559
  • 989805608831 / U1028969
  • 989805608841 / U1028970
  • 989805608851 / U1038140
  • 989805604231 / 1023384

Distribution

Distributed in 14 states:

Same manufacturer · Childrens Medical Ventures

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