Device recall
Z-0011-2022: ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280…
FDA device recall · Class II · Welch Allyn Inc Mortara
Key facts
| Recall number (Z-number) | Z-0011-2022 |
|---|---|
| Recall event | 88501 |
| Product | ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX, ELI280-BCB-AAAAX, ELI280-DDB-ACAAX, ELI280-DBA-BAFAX, ELI280-DCB-AAAAX, ELI280-DBA-AAFBD, ELI280-AAA-AAEBX… |
| Product code | DPS |
| Recalling firm | Welch Allyn Inc Mortara |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K122073 |
| FEI number | 2183461 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database