FDA Device Intelligence
Home › Barrier Technologies, LLC › SecureShield© Multipurpose with fenestration 12" x 17" Scatter Reducing Drape

SecureShield© Multipurpose with fenestration 12" x 17" Scatter Reducing Drape

Barrier Technologies, LLC · Model SS-5200 · UDI-DI 10860004894633

KPY
10
510(k) clearances
71
Adverse events
2
Recalls
193
Facilities

Description

Outstanding protection during all types of biopsy procedures. Rectangular fenestration allows access and viewing while minimizing radiation exposure. The SecureShield Biopsy Shield provides excellent protection during any needle biopsy or puncture procedure. This versatile shield can be effectively used at any location on the body.

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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.