FDAFDA · Food and drugs·Recall number Z-2526-2023
Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator
Published September 27, 2023 · Recall initiated: July 26, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hamilton Medical, Inc.
- Distributor
- Distribution US nationwide, including Puerto Rico. OUS: Not provided
- Lot
- 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
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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