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FDA Recall Z-0896-05 · Posted 2005-06-16
Recalling FirmPhilips Medical Systems North America Co. Phillips
Recall StatusTerminated
Product CodeLLZ
Date Initiated2005-04-29
Date Terminated2008-05-09
Product Quantity18 units
Reason for Recall
Automated analysis of vascular obstruction tool in software gives unreliable calibration and analysis results when using unprocessed images acquired on the Philips Allura FD10.
Firm Action
On 4/29/05 the firm mailed a letter, via certified return receipt. to their customers. The letter notified users of the problem and offered a work around. Consignees were advised they would be contacted by a representative to upgrade the unit with new software.
Root Cause
Other
Distribution Pattern
The units were distributed to 18 medical centers thorughout the US.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.