The device's marketing brochure states: "IntelliVue M3150 Information Center...Philips Medical Systems". The beige-color
FDA device recall Z-0034-2011 · posted 2010-10-08 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- Potential for Internal Sound Amplifier to malfunction which could delay treatment.
- Action taken
- On 11/20/08, Philips began sending the URGENT-Medical Device Correction letter to their consignees via e-mails. On 11/21/08, the firm sent out the recall letter via United State Postal Service. The letter states the affected device as Philips IntelliVue Information Centers, running on the HP rp5700 PC platform equipped with an active speaker solutions using a DB-15 to 3.5 mm cable set. The consignees are advised to ensure that the audible alarm system is clear, free of noise and distortion and adjustable to different sound levels which is explained in p. 5-47 "Adjusting Alarm Tone Volume" of IntelliVue of the Instruction for Use, Release K Manual, supplied with the hardware, Philips Part Number 453564062301. Consignees can call Philips Healthcare Customer Care Service Center at 1-800-722-9377, #3, #1 and reference FCO 99862012.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- DSI
- Quantity affected
- 424 units in US.
- Distribution
- Nationwide Distribution
- Date initiated
- 2008-11-21
- Date posted
- 2010-10-08
- Date terminated
- 2010-10-12
- Location
- Bothell, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.O (K023698) | Philips Medical Systems | 2002-11-19 |