Recall Z-0034-2011 ยท DSI Detector And Alarm, Arrhythmia
Philips Medical Systems North America Co. Phillips
The device's marketing brochure states: "IntelliVue M3150 Information Center...Philips Medical Systems". The beige-colored PAS-210 external speakers can be identified by their use of DB15-to-3.5 mm mini-phone jack cable (Agispec-081Y-4 or Agispec-081-6) to connect to the rp5700 PC. Indicated for central monitoring of multiple adult, pediatric, and neonatal patients.
| Date | Oct 8, 2010 (initiated Nov 21, 2008) |
| Status | Terminated |
| Reason | Potential for Internal Sound Amplifier to malfunction which could delay treatment. |
| Root cause | Component change control |
| Action | 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" o |
| Quantity | 424 units in US. |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023698 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.O Philips Medical Systems, Nov 19, 2002 |