Z-2528-2023 Class I Ongoing

Recalled by Hamilton Medical, Inc. — Reno, NV

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