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Microtek Medical LLC · Model Drape Armour FPS · UDI-DI 00748426261925

KPY Prescription
10
510(k) clearances
71
Adverse events
2
Recalls
192
Facilities

Description

DRAPE ARMOUR™ Low, Free Positional Protection Shield, 30 cm x 86 cm (12 in x 34 in), Attenuation: 82% - 84% at 90 kVp

Recalls

DateFirmReason
2015-03-09GE HealthcareGE Healthcare has recently become aware of an improper installation of a ceiling suspended pendent supporting a radiation shield and/or surgical lamp. The pendent system was not in
2014-05-02GE Healthcare, LLCGE Healthcare has recently become aware of a potential safety issue due to the improper installation of a Kenex ceiling suspended radiation shield and surgical lamp. This issue is

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.