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FDA (Device enforcement)Recalled 2014-04-29closedclass ii

Childrens Medical Ventures: Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.

Is my product affected?

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

  • UPC 989805603611
  • UPC 989805603631
  • UPC 989805604511
  • UPC 989805604521
  • UPC 989805604531
  • UPC 989805604631
  • UPC 989805605051
  • UPC 989805605061
  • UPC 989805608801
  • UPC 989805608811
  • UPC 989805608831
  • UPC 989805608841
  • UPC 989805608851
  • UPC 989805604231

Check against the official notice below — it lists the full affected range.

What happened

Philips/Children's Medical Ventures is recalling 112 Smart Monitor 2 Professional Series infant apnea monitors due to improperly assembled battery pack wire harnesses. The defect causes the devices to display an error code and sound repeated alarms when powered on, preventing them from functioning. The recalled units were distributed worldwide to the USA, Australia, Belgium, and Canada across multiple lot and code numbers.

The source does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The battery pack wire harness is improperly assembled rendering the device inoperable. The wiring issue causes an error code to be displayed and results in the device sounding an alarm repeatedly at power up. The presence of the error code and the devices alarm prevents the device from functioning until the issue is addressed.

Details from the source

Reason for recall: The battery pack wire harness is improperly assembled rendering the device inoperable. The wiring issue causes an error code to be displayed and results in the device sounding an alarm repeatedly at power up. The presence of the error code and the devices alarm prevents the device from functioning until the issue is addressed. Distribution: Worldwide Distribution - USA including the states of MI, WI, SC, FL, TX, KS, MA, AZ, UT, WV, IN, MN, NV and VA., and the countries of Australia, Belgium and Canada. Quantity: 112 Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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