FDA Device Recall Z-2528-2023

Hamilton Medical, Inc. · Reno, NV

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

Hamilton-MR1, REF: 161010, Intensive Care Ventilator

Lot / serial / GTIN: UDI: 07630002800761 & 07630002813556 / Affected Serial Numbers: 3422 3423 3424 3425 3426 3427 3428 3429 3469 3503 3510 3800

Quantity: 12 units

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.

Recall record

Recall number: Z-2528-2023
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Distribution US nationwide, including Puerto Rico. OUS: Not provided
Recall initiated: 2023-07-26
Classified by FDA Center: 2023-09-20
FDA published: 2023-09-27
Recalling firm: Hamilton Medical, Inc.
Firm location: Reno, NV

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All device recalls