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Terminated

IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8

FDA Recall Z-1676-2011 · Posted 2011-03-16

Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2011-02-10
Date Terminated2011-09-15
Product QuantityOne

Reason for Recall

A discrepancy in the validation testing which resulted in the product not performing as intended.

Firm Action

AGFA sent an "URGENT SAFETY NOTICE" letter dated 2/10/11 via FED-EX to the customer. The letter included an acknowledgment which was to be FAX-Back indicating that the information was received and understood. Agfa has discussed with the customer how the de-installation of their CRS Remote product - Software Version 7.8_HL would be performed.

Root Cause

Device Design

Distribution Pattern

TX

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050228AGFA HEARTLAB CARDIOVASCULARHeartlab, Inc. · 2005-02-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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