Home › Barrier Technologies, LLC › SecureShield© EP 12" x 17" Scatter Reducing Drape
SecureShield© EP 12" x 17" Scatter Reducing Drape
Barrier Technologies, LLC · Model SS-5400 · UDI-DI 10860004894657
10
510(k) clearances
71
Adverse events
2
Recalls
193
Facilities
Description
Excellent protection for device implant procedures such as Bi-V pacing, etc. Specially designed scoop fenestration allows easy access to site and maximum radiation protection. Specifically designed to protect the physician’s hand, body and head. The unique half-moon fenestration is large enough to allow easy access at the entry point, but small enough to block dangerous scatter radiation.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-03-09 | GE Healthcare | GE 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 |
| 2014-05-02 | GE Healthcare, LLC | GE 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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Get your free API keyRead the docsData 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.