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Paneffort

Paneffort, LLC · Model ACF-FMHB-9RU · UDI-DI 10810101310482

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

Description

Disposable Anti-Fog Face Shield. Full Length, Foam Head Protection, Elastic Head Band. Regular/Large

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.