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BURLINGTON MEDICAL, LLC · Model RCCPB-OS · UDI-DI 00840331275902

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

Description

RCCPB-OS (BLANKET, .5MM COST CRUNCHER, PROTECTIVE BLANKET, 24" X 36")

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.