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Recall Observatory FDA recall evidence

Device 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.

Z-1942-2012

June 14, 2012

Class II

Product summary

Firm
Philips Healthcare Inc.
Event
Event 62270
Status
Terminated
Classification
Class II
Quantity
226 units
Official record key
device-enforcement:Z-1942-2012

Official wording

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

Code information: Software R2.1 L 1 SP2

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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