Hamilton Medical, Inc.: Hamilton Ventilators Recalled for Risk of Power Short and Breathing Interruption

Agency Publication Date: September 20, 2023

Summary

Hamilton Medical, Inc. is recalling 1,478 portable and intensive care ventilators, including Hamilton-C1, T1, and MR1 models, along with specific spare parts. These medical devices are being recalled because electrical capacitors on the internal control boards may degrade and leak fluid (electrolyte). This leakage can cause a short circuit on the board or cause the capacitor to fail entirely, which can lead to a sudden and unexpected stop in patient ventilation. Consumers should contact the manufacturer immediately to determine if their specific unit or spare parts are affected by this voluntary safety action.

Risk

If the capacitor leaks electrolyte onto the control board, it can cause a short circuit that immediately stops the ventilator from functioning. This failure could result in an interruption of life-sustaining breathing support for patients, posing a critical risk of serious injury or death.

What You Should Do

Check the serial number on your Hamilton-C1 (REF: 161001), Hamilton-T1 (REF: 161006, 161009), or Hamilton-MR1 (REF: 161010) ventilator to see if it matches any of the affected numbers provided in this recall.
If you have spare parts in stock, check for Control Board Spare Parts (REF: MSP161502/12) with serial numbers 4001901, 4002139, 4003445, 4003567, 4003576, or 4005595.
Inspect your inventory for ESM Shielding Sets (REF: MSP161339/02) with serial numbers 4050193, 4050210, 4050194, or 4016669.
Contact your healthcare provider or Hamilton Medical, Inc. at 1-800-426-6331 to verify if your device is affected and to receive specific instructions regarding the replacement of degrading components.
Report any adverse events or malfunctions associated with these ventilators to the FDA's MedWatch program at 1-800-332-1088 or online at www.fda.gov/medwatch.
For further information or questions regarding this recall, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Contact the manufacturer or healthcare provider for instructions on component replacement and safety checks.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Hamilton-C1 Portable Intensive Care Ventilator

Model / REF:

REF: 161001

UPC Codes:

07630002800747

07630002813426

Lot Numbers:

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

Product: Hamilton-T1 Intensive Care and Transport Ventilator (Model 161006)

Model / REF:

REF: 161006

UPC Codes:

07630002801850

07630002813532

Lot Numbers:

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

Product: Hamilton-T1 Intensive Care and Transport Ventilator (Model 161009)

Model / REF:

REF: 161009

UPC Codes:

07630002806091

07630002813549

Lot Numbers:

Serial Numbers: 500816 to 511496 (multiple ranges - see documentation)

Product: Hamilton-MR1 Intensive Care Ventilator

Model / REF:

REF: 161010

UPC Codes:

07630002800761

07630002813556

Lot Numbers:

Serial Numbers: 3422, 3423, 3424, 3425, 3426, 3427, 3428, 3429, 3469, 3503, 3510, 3800

Product: Hamilton C1/T1/MR1 Control Board Spare Part

Model / REF:

REF: MSP161502/12

UPC Codes:

07630002805247

Lot Numbers:

Serial Numbers: 4001901, 4002139, 4003445, 4003567, 4003576, 4005595

Product: Hamilton-T1 ESM Shielding Set Spare Part

Model / REF:

REF: MSP161339/02

UPC Codes:

07630002800761

Lot Numbers:

Serial Numbers: 4050193, 4050210, 4050194, 4016669

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92873

Status: Active

Manufacturer: Hamilton Medical, Inc.

Sold By: Authorized Medical Device Distributors; Hamilton Medical, Inc.

Manufactured In: United States

Units Affected: 6 products (164 units; 76 units; 1216 units; 12 units; 6 units; 4 shielding set)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check the serial number on your Hamilton-C1 (REF: 161001), Hamilton-T1 (REF: 161006, 161009), or Hamilton-MR1 (REF: 161010) ventilator to see if it matches any of the affected numbers provided in this recall.

If you have spare parts in stock, check for Control Board Spare Parts (REF: MSP161502/12) with serial numbers 4001901, 4002139, 4003445, 4003567, 4003576, or 4005595.

Inspect your inventory for ESM Shielding Sets (REF: MSP161339/02) with serial numbers 4050193, 4050210, 4050194, or 4016669.

Contact your healthcare provider or Hamilton Medical, Inc. at 1-800-426-6331 to verify if your device is affected and to receive specific instructions regarding the replacement of degrading components.

Report any adverse events or malfunctions associated with these ventilators to the FDA's MedWatch program at 1-800-332-1088 or online at www.fda.gov/medwatch.

For further information or questions regarding this recall, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: Hamilton-C1 Portable Intensive Care Ventilator

Model / REF:

REF: 161001

UPC Codes:

07630002800747

07630002813426

Lot Numbers:

Product: Hamilton-T1 Intensive Care and Transport Ventilator (Model 161006)

Model / REF:

REF: 161006

UPC Codes:

07630002801850

07630002813532

Lot Numbers:

Product: Hamilton-T1 Intensive Care and Transport Ventilator (Model 161009)

Model / REF:

REF: 161009

UPC Codes:

07630002806091

07630002813549

Lot Numbers:

Serial Numbers: 500816 to 511496 (multiple ranges - see documentation)

Product: Hamilton-MR1 Intensive Care Ventilator

Model / REF:

REF: 161010

UPC Codes:

07630002800761

07630002813556

Lot Numbers:

Serial Numbers: 3422, 3423, 3424, 3425, 3426, 3427, 3428, 3429, 3469, 3503, 3510, 3800

Product: Hamilton C1/T1/MR1 Control Board Spare Part

Model / REF:

REF: MSP161502/12

UPC Codes:

07630002805247

Lot Numbers:

Serial Numbers: 4001901, 4002139, 4003445, 4003567, 4003576, 4005595

Product: Hamilton-T1 ESM Shielding Set Spare Part

Model / REF:

REF: MSP161339/02

UPC Codes:

07630002800761

Lot Numbers:

Serial Numbers: 4050193, 4050210, 4050194, 4016669

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92873

Status: Active

Manufacturer: Hamilton Medical, Inc.

Sold By: Authorized Medical Device Distributors; Hamilton Medical, Inc.

Manufactured In: United States

Units Affected: 6 products (164 units; 76 units; 1216 units; 12 units; 6 units; 4 shielding set)

Distributed To: Nationwide