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Terminated

Optimus 30

FDA Recall Z-1084-05 · Posted 2005-11-08

Recalling FirmPhilips Ultrasound, Inc.
Recall StatusTerminated
Product CodeKPR
Date Initiated2005-02-24
Date Terminated2010-09-27
Product Quantity44 units

Reason for Recall

Systems do not comply with the labeling performance standards.

Firm Action

On/about 2/24/04 the firm''s representatives began visiting sites to apply appropriate labeling. The firrm''s representatives will test units to verify compliance.

Root Cause

Other

Distribution Pattern

Devices were distributed to 38 medical centers and hospitals throughout the US.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K945278PHILIPS BUCKY DIAGNOST FAMILYPhilips Medical Systems North America, Inc. · 1994-12-14

Official Source

View FDA Recall →

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

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