Home › Bracco Injeneering SA › EmpowerMR® Injector System without Remote Control
EmpowerMR® Injector System without Remote Control
Bracco Injeneering SA · Model 017377 · UDI-DI 47630039300973
IZQ
Prescription
1
510(k) clearances
583
Adverse events (18 deaths)
3
Recalls
43
Facilities
Description
Composed of: 1 x Hydraulic Controller 1 x Injector Head 1 x Electro-Hydraulic Interconnect
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.