Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX The intended use of the Inform
FDA device recall Z-0495-2013 · posted 2012-12-10 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- Internal audio cable may have diminished retention force due to damaged contacts, which could lead to intermittent or loss of audible alarms.
- Action taken
- Philips sent an URGENT - Medical Device Correction letter dated November 9, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Philips is conducting a voluntary correction to replace the audio cable on affected devices. Customer were instructed to follow the "Action to be taken by CustomerUser" section of the instructions. Customers with wquestions were instructed to contact their Phililps representataive or contact the Customer Care Solutions Center at (800) 722-9377. For questions regarding this recall call 978-687-1501.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 3165
- Distribution
- Worldwide Distribution - USA (nationwide) and Canada.
- Date initiated
- 2012-11-09
- Date posted
- 2012-12-10
- 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 |
|---|---|---|
| M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0 (K102495) | Philips Medical Systems | 2010-09-30 |
| M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00 (K081983) | Philips Medical Systems | 2008-08-22 |