—#114593

Product

Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.

FDA product code: MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K081983, K102495
Affected lot / code info: PIIC 865435 M3140 Information Center Low Acuity 865436 M3150 Information Center Local DB 865417 M3145 Information Center Small NW DB 865418 M3155 Information Center NW DB 865415 M3151 Information Center Client 865421 M3170 Patient Link 865416 M3177 Trend Display 865422 M3140 Upgrade 865423 M3150 Upgrade 865426 M3145 Upgrade 865427 M3155 Upgrade 865424 M3151 Upgrade 865266 - M3140 Information Center Low Acuity 865267 M3150 Information Center Local DB 865269 M3145 Information Center Small NW DB 865268 M3155 Information Center NW DB 865270 M3151 Information Center Client 865274 M3170 Patient Link 865271 M3177 Trend Display 865277 M3140 Upgrade 865278 M3150 Upgrade 865281 M3145 Upgrade 865282 M3155 Upgrade 865279 M3151 Upgrade PIIC iX 866023 IntelliVue Info Center iX 866117 PIIC Classic Upgrade 866027 PIIC iX HW Upgrade

Why it was recalled

Internal audio cable may have diminished retention force due to damaged contacts, which could lead to intermittent or loss of audible alarms.

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and Canada.

Timeline

Recall initiated: 2012-11-09
Posted by FDA: 2012-12-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114593. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.