Z-2530-2023 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
4 shielding set

Product Description

Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for 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 / Affected Serial Numbers: 4050193, 4050210, 4050194 and 4016669