Home › BURLINGTON MEDICAL, LLC › BREASTSHIELD
BREASTSHIELD
BURLINGTON MEDICAL, LLC · Model RSLPBS-SET · UDI-DI 00840331274110
10
510(k) clearances
71
Adverse events
2
Recalls
192
Facilities
Description
RSLPBS-SET (BREAST SHIELDS, .5MM STARLITE, PEDIATRIC BREAST SHIELDS, SET OF 3, CHILD)
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 |
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 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.