Device recall
Z-1615-2012: QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04…
FDA device recall · Class III · Intel-GE Care Innovations LLC
Key facts
| Recall number (Z-number) | Z-1615-2012 |
|---|---|
| Recall event | 61719 |
| Product | QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 (USA) and QCE200403, v.02; QCE200403, v.03 (UK). Manufacturer Living Independently Group, Inc., New York, NY. QuietCare is intended for use in monitoring the environmental conditions and activity (motion) of an… |
| Product code | IQA |
| Recalling firm | Intel-GE Care Innovations LLC |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 21, 2012 |
| FEI number | 3008850109 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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