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EmpowerCTA®+ Injector System with EDA
Bracco Injeneering SA · Model 017383 · UDI-DI 47630039300447
10
510(k) clearances
6
Adverse events
2
Recalls
66
Facilities
Description
Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1x Remote Control GTIN : 37630039300471 1 x EDA Module Kit GTIN : 37630039300426 1 x EmpowerSync® Power Supply GTIN : 37630039300488 1 x Injector GTIN : 37630039300747
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-09-02 | Baxter Healthcare Corporation | Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards. |
| 2015-12-01 | Partners In Medicine Llc | Device non-conformity which may lead to an incorrect oscillometric measurement of upper arm blood pressure values in some subjects - mainly in tall and slim persons (overestimation |
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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.