Device recall
Z-1315-2012: QRS Diagnostic Universal ECG 12 Channel ECG (IEC), Rx only, REF Z-7000-0400…
FDA device recall · Class II · Qrs Diagnostic
Key facts
| Recall number (Z-number) | Z-1315-2012 |
|---|---|
| Recall event | 61282 |
| Product | QRS Diagnostic Universal ECG 12 Channel ECG (IEC), Rx only, REF Z-7000-0400, Manufactured for QRS Diagnostic, 14755 27th Ave North, Plymouth, MN 55447 USA. Product Usage: The Universal ECG is an Electrocardiograph Diagnostic System designed to provide measurements and interpretative statements of a… |
| Product code | LOS |
| Recalling firm | Qrs Diagnostic |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 2, 2012 |
| 510(k) numbers | K990266 |
| FEI number | 1000520092 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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