Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700..
FDA device recall Z-2057-2015 · posted 2015-07-10 · Terminated
Recall details
- Recalling firm
- Hamilton Medical, Inc.
- Reason for recall
- Customer reports that the ventilator display can freeze. Ventilation continues but the information is no longer displayed on the screen and the user can no longer operate the device.
- Action taken
- *** Please note *** This is not a new recall. An error occurred, and this recall was originally classified as a class I on July 10, 2015. No further action is required. Hamilton Medical AG notified their customers with a letter dated February 19, 2015 and had a fix (SW 2.42) that was available as of February 20th 2015. Hamilton Medical proceeded to send out notification letters the 24th of March 2015 once they compiled the complete and validated list of customers that had the affected software. Customers with questions were instructed to call 800-426-6331, ext.215.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 248
- Distribution
- Nationwide Distribution
- Date initiated
- 2015-03-24
- Date posted
- 2015-07-10
- Date terminated
- 2015-12-23
- Location
- Reno, NV
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HAMILTON-G5 (K131774) | Hamilton Medical AG | 2013-10-09 |
| HAMILTON-G5 (K103803) | Hamilton Medical AG | 2011-11-23 |