FDAClass ISeptember 27, 2023

Hamilton-T1 recall

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

Why was Hamilton-T1 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI: 07630002800761 / Affected Serial Numbers: 4050193, 4050210, 4050194 and 4016669

Product
Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator
Recalling firm
Hamilton Medical, Inc.
Quantity
4 shielding set
Distribution
Distribution US nationwide, including Puerto Rico. OUS: Not provided
Recall date
September 27, 2023
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls