Agency classClass IOur severity:Severe FDA (Devices)·Z-1525-2022·Announced 2022-08-31

Intensive care ventilator status board may loosen, causing water damage and malfunction

Hamilton's HAMILTON-C6 intensive care ventilator status indicator board may become loose, allowing water or disinfectants to enter the device and cause technical faults that could force the ventilator into unsafe modes where patients breathe unassisted room air.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA has classified this as a Class I medical device recall, which indicates products with a reasonable probability of causing serious adverse health consequences. This classification mandates a minimum Severe rating. A ventilator that can fail to deliver assisted breathing to a dependent patient represents a critical safety hazard.

Plain-English summary

Hamilton Medical AG is recalling 358 HAMILTON-C6 Intensive Care Ventilators (REF: 160021). The units were distributed nationwide in the United States, including Puerto Rico.

The ventilator's status indicator board can become loose. This loosening may allow water or disinfectants to seep into the device, potentially causing multiple technical fault alarms in rapid succession.

When multiple technical faults occur in a short time, the ventilator may automatically shift into Safety Ventilation mode (with the blower running constantly) or Ambient State mode (where the inspiratory and expiratory valves open and the patient breathes room air without assistance). In these modes, a 'Panel connection lost' message is displayed. The ventilator no longer delivers assisted breathing to the patient.

Healthcare facilities and clinicians should verify that their HAMILTON-C6 units are not among those recalled. Contact Hamilton Medical AG or the FDA for the list of affected serial numbers and guidance on corrective actions.

The recalled product

Product: HAMILTON-C6 Intensive Care Ventilator, REF: 160021
Manufacturer: Hamilton Medical AG
Category: Medical Device — Critical Care Ventilator
Hazard: water-ingress
device-malfunction
ventilation-failure
Affected units: 358

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

UDI-DI: 07630002808590
Serial Numbers: 5663
6995
6907
6952
7177
7772
6932
6157
8658
7307
5939
6858
6231
8620
6349
8356
6480
8322
8306

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Hamilton Medical AG

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Same hazard · water ingress