Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator
FDA device recall Z-2526-2023 · posted 2023-09-20 · Open, Classified
Recall details
- Recalling firm
- Hamilton Medical, Inc.
- Reason for recall
- Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.
- Action taken
- On July 26, 2023, Hamilton Medical issued Urgent Medical Device Correction via E-Mail. Hamilton Medical asked consignees to take the following actions 1. Check for affected devices in your facility. Get in contact with your local distribution partner and get the devices serviced with high priority. 2. Please sign the enclosed/attached sheet to confirm that, as an End- Customer, you have received and duly noted this Medical Device Correction.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- CBK
- Quantity affected
- 76 units
- Distribution
- Distribution US nationwide, including Puerto Rico. OUS: Not provided
- Date initiated
- 2023-07-26
- Date posted
- 2023-09-20
- Location
- Reno, NV
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HAMILTON-T1, HAMILTON-C1 (K181216) | Hamilton Medical AG | 2019-08-02 |