PlainRecalls
FDA Devices Critical Class I Ongoing

Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator

Reported: September 27, 2023 Initiated: July 26, 2023 #Z-2530-2023

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.

Details

Recalling Firm
Hamilton Medical, Inc.
Units Affected
4 shielding set
Distribution
Distribution US nationwide, including Puerto Rico. OUS: Not provided
Location
Reno, NV

Frequently Asked Questions

What product was recalled?
Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator. Recalled by Hamilton Medical, Inc.. Units affected: 4 shielding set.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 27, 2023. Severity: Critical. Recall number: Z-2530-2023.