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EmpowerCTA®+ Injector System
Bracco Injeneering SA · Model 017285 · UDI-DI 47630039300904
10
510(k) clearances
583
Adverse events (18 deaths)
3
Recalls
43
Facilities
Description
Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1 x Remote Control GTIN : 37630039300471 1 x EmpowerSync® Power Supply GTIN : 37630039300839 1 x Injector GTIN : 37630039300891
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-10-11 | Mallinckrodt Inc | Syringes packaged and labeled as the Illumena 150mL Linden Luer Syringe with Handi-Fil Straw, product 900103, contained the Illumena 150mL Syringe with Handi-Fil Straw, product 900 |
| 2011-05-20 | Mallinckrodt Inc | Syringes packaged and labeled as the Illumena 150mL Linden Luer Syringe with Handi-Fil Straw, product 900103, contained the Illumena150mL Syringe with Handi-Fil Straw, product 9001 |
| 2008-04-07 | Mallinckrodt Inc | Screws can begin to loosen and shear off to the point of the J-Bow falling from the suspension system. This may cause injury to patients or hospital staff. |
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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.