Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator
- Company
- Hamilton Medical Inc
- Recall Initiated
- July 26, 2023
- Posted
- September 20, 2023
- Recall Number
- Z-2530-2023
- Quantity
- 4 shielding set
- Firm Location
- Reno, NV
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.
Distribution
Distribution US nationwide, including Puerto Rico. OUS: Not provided
Lot / Code Info
UDI: 07630002800761 / Affected Serial Numbers: 4050193, 4050210, 4050194 and 4016669
Root Cause
Nonconforming Material/Component
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.