Z-2526-2023Class I

Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator

Name: Z-2526-2023 Hamilton-T1, REF: 161006, Intensive Care and Transport 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-T1, REF: 161006, Intensive Care and Transport 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-2526-2023
Classification: Class I
Status: Open, Classified
Initiated: 2023-07-26
Posted: 2023-09-20
Recalling firm: Hamilton Medical AG
Product: Hamilton-T1, REF: 161006, Intensive Care and Transport 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: 76 units
Distribution: Distribution US nationwide, including Puerto Rico. OUS: Not provided
Product codes and lots: UDI: 07630002801850 & 07630002813532 / Affected Serial Numbers: 15929 17600 17661 17677 17698 17699 17741 17850 17877 17913 17925 17955 17957 17969 17975 17976 17982 17985 17986 17991 17993 17995 18009 18166 18183 18189 18191 18199 18224 18244 18251 18255 18256 18260 18263 18272 18273 18276 18288 18289 18305 18308 18333 18340 18349 18360 18363 18377 18378 18383 18414 18415 18419 18441 18451 18458 18461 18502 18537 18544 18550 18778 18784 19237 19290 19291 19292 19293 19294 19298 19304 19305 19470 19483 19490 26117

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2526-2023
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

K181216Class IIHamilton-T1, Hamilton-C1Hamilton Medical AG / cleared 2019-08-02

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)