Recall archive / FDA device enforcement
Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator — FDA record Z-2525-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 26, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator
- Reason
- 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.
- Classification
- Class I
- Recalling firm
- Hamilton Medical, Inc.
- Quantity
- 164 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2525-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI: 07630002800747 & 07630002813426 / Affected Serial Numbers: 24177 24196 24216 24217 24219 24247 24250 24324 24360 24370 24431 24460 24467 24480 24487 24511 24523 24552 24556 24557 24558 24561 24564 24565 24571 24572 24574 24578 24583 24587 24591 24595 24612 24616 24620 24622 24651 24662 24672 24691 24965 24991 25006 25010 25011 25014 25022 25096 25109 25111 25118 25141 25142 25151 25152 25158 25163 25169 25171 25178 25183 25184 25185 25187 25189 25231 25232 25370 25433 25437 25456 25511 25516 25534 25538 25559 25576 25578 25612 25628 25632 25636 25678 25690 25712 25716 25721 25745 25747 25750 25753 25756 25757 25758 25759 25760 25761 25762 25763 25764 25769 25771 25777 25782 25784 25794 25809 25817 25822 25823 25830 25832 25834 25835 25841 25851 25852 25853 25862 25888 25893 25907 25913 25919 25924 25938 26007 26011 26042 26052 26063 26064 26069 26071 26081 26087 26201 26363 26390 26502 26510 26516 26639 26640 26641 26652 26660 26725 26731 26732 26733 26803 26857 26859 26870 26893 26896 26944 26977 27201 27504 27571 29013 31746 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distribution US nationwide, including Puerto Rico. OUS: Not provided
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Sep 27, 2023
- Recall initiation date
- Jul 26, 2023
- Center classification date
- Sep 20, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.