Recall Z-2530-2023 ยท CBK Ventilator, Continuous, Facility Use
Hamilton Medical, Inc.
Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator
| Date | Sep 20, 2023 (initiated Jul 26, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 4 shielding set |
| Distribution | Distribution US nationwide, including Puerto Rico. OUS: Not provided |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.