Philips M8102A IntelliVue MP2 Model: 865040 Indicated for use by health care professionals whenever there is a need for
FDA device recall Z-2626-2010 · posted 2010-09-29 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- Speakers on the Philips IntelliVue X2 and MP2 patient monitors may fail, causing absence of an audible alarm and delaying patient treatment.
- Action taken
- Philips issued a URGENT - MEDICAL DEVICE letter dated August 26, 2010, to each affected customer. The Urgent Medical Device Correction notification/Field Safety Notice informs customers of the issue and gives instructions on actions to take while awaiting their replacement speaker assemblies. The speaker replacement assembly is expected to be available in 8 weeks. Affected products may continue to e used while awaiting replacement of the speaker, provided that the user routinely checks for the display of the "Speaker Malfunct." INOP at power-up. If you experience this INOP or there is no sound from your X2/MP2 speaker while it is not connected to another audible alarm annunciation system, remove the device from use and contact your local Philips service representative at 1-800-722-9377.
- Root cause
- Process design
- Status
- Terminated
- Product code
- DSI
- Quantity affected
- 2,832 UNITS
- Distribution
- Worldwide Distribution - USA and the countries of : ARGENTINA AUSTRALIA AUSTRIA BAHRAIN BANGLADESH BELGIUM BRAZIL CHINA CZECH REPUBLIC DENMARK EGYPT ESTONIA FINLAND FRANCE GERMANY GREECE HONG KONG HUN
- Date initiated
- 2010-08-31
- Date posted
- 2010-09-29
- Date terminated
- 2017-02-15
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTELLIVUE PATIENT MONITOR, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, AND MP90 (K083517) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009-01-16 |