Z-2528-2023 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 27, 2023
- Initiation Date
- July 26, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 units
Product Description
Hamilton-MR1, REF: 161010, Intensive Care Ventilator
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 Pattern
Distribution US nationwide, including Puerto Rico. OUS: Not provided
Code Information
UDI: 07630002800761 & 07630002813556 / Affected Serial Numbers: 3422 3423 3424 3425 3426 3427 3428 3429 3469 3503 3510 3800