—#110035

Product

Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange. Philips Xcelera Connect R2.x is a generic interface and data mapping engine between a Hospital Information System (HIS), Imaging Modalities, Xcelera PACS and Xcelera Cath Lab Manager (CLM). This interface engine simplifies the connection by serving as a central point for data exchange. The data consists only of demographic patient information, schedules, textual information and text reports.

FDA product code: OUG — Medical Device Data System
Device class: Class 1
Medical specialty: General Hospital
Affected lot / code info: Software R2.1 L 1 SP2

Why it was recalled

Xcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatted reports interface

Root cause (FDA determination)

Software design

Action the firm took

Philips Healthcare sent an "URGENT-FIELD SAFETY NOTICE" letter dated June 1, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Philips representative will contact customers when the upgrade becomes available. Contact your local Philips Representative for questions concerning this issue.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Argentina, Chile, Denmark , Estonia, Finland, France, Germany ,Hong Kong, Ireland, Italy, Malaysia, Netherlands, Poland, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Taiwan, United Kingdom, and Utd. Arab. Emir.

Timeline

Recall initiated: 2012-06-14
Posted by FDA: 2012-07-05
Terminated: 2017-03-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #110035. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.