Z-2528-2023Class I

Hamilton-MR1, REF: 161010, Intensive Care Ventilator

Name: Z-2528-2023 Hamilton-MR1, REF: 161010, Intensive Care Ventilator
Creator: Hamilton Medical, Inc.
Published: 2023-07-26
License: https://open.fda.gov/license/

Hamilton Medical AG / initiated 2023-07-26 / Open, Classified / root cause: manufacturing process

FDA source

Hamilton Medical, Inc. began a recall of Hamilton-MR1, REF: 161010, Intensive Care Ventilator on 2023-07-26. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2528-2023
Classification: Class I
Status: Open, Classified
Initiated: 2023-07-26
Posted: 2023-09-20
Recalling firm: Hamilton Medical AG
Product: Hamilton-MR1, REF: 161010, Intensive Care Ventilator
Product code: CBK Ventilator, Continuous, Facility Use
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On July 26, 2023, Hamilton Medical issued Urgent Medical Device Correction via E-Mail. Hamilton Medical asked consignees to take the following actions 1. Check for affected devices in your facility. Get in contact with your local distribution partner and get the devices serviced with high priority. 2. Please sign the enclosed/attached sheet to confirm that, as an End- Customer, you have received and duly noted this Medical Device Correction.
Quantity in commerce: 12 units
Distribution: Distribution US nationwide, including Puerto Rico. OUS: Not provided
Product codes and lots: UDI: 07630002800761 & 07630002813556 / Affected Serial Numbers: 3422 3423 3424 3425 3426 3427 3428 3429 3469 3503 3510 3800

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2528-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2525-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-20
Z-2526-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-20
Z-2527-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-20
Z-2528-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-20
Z-2529-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-20
Z-2530-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-20

Product code CBK

K153046Class IIHamilton-Mr1Hamilton Medical AG / cleared 2016-09-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)