HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The HAMILTON-G5 ventilator is des
FDA device recall Z-0151-2016 · posted 2015-11-04 · Terminated
Recall details
- Recalling firm
- Hamilton Medical, Inc.
- Reason for recall
- Ventilation and alarms of a HAMILTON-G5 ventilator can be suppressed unintentionally after the activation of a suctioning maneuver by the operator; this situation can occur regardless of the selected patient group (neonatal, pediatric and adult).
- Action taken
- Hamilton Medical issued a letter dated April 22, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were notified that their Hamilton Medical Account Manager would contact them to coordinate the deactivation of the Ventilation Suppression feature. Customers were asked to review the Medical Device Field Safety Corrective Action. Customers with questions were instructed to call 800-426-6331, Ext 215.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 1128
- Distribution
- Nationwide Distribution
- Date initiated
- 2014-04-22
- Date posted
- 2015-11-04
- Date terminated
- 2017-08-24
- Location
- Reno, NV
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HAMILTON-G5 (K131774) | Hamilton Medical AG | 2013-10-09 |