[Recalled] Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic respiratory failure or during resuscitation by providing continuous positiv
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic respiratory failure or during resuscitation by providing continuous positive -pressure ventilation. |
|---|---|
| Brand / manufacturer | Impact Instrumentation, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2152-2012 |
| Country of notice | United States |
| Risk level | Class III |
| Hazard type | recall |
| Notice date | 19 March 2012 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Ten units of Model EMV+ Devices were shipped out in error before the verification and validation was completed for a new integrated circuit (IC) on the CPU PCB.
This Class III recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Impact Instrumentation, Inc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.