Hamilton-MR1 recall
Hamilton-MR1, REF: 161010, Intensive Care Ventilator
Why was Hamilton-MR1 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 & 07630002813556 / Affected Serial Numbers: 3422 3423 3424 3425 3426 3427 3428 3429 3469 3503 3510 3800
- Product
- Hamilton-MR1, REF: 161010, Intensive Care Ventilator
- Recalling firm
- Hamilton Medical, Inc.
- Quantity
- 12 units
- Distribution
- Distribution US nationwide, including Puerto Rico. OUS: Not provided
- Recall date
- September 27, 2023
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)