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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
- Manufacturer
- Childrens Medical Ventures
- Category
- Medical Device — Infant 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
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