MalfunctionBSZ

Carestation 620

Received Jul 30, 2026 · Event occurred Jul 21, 2026

Report 2112667-2026-04796 · MDR key 50085338

Device

Generic name

Anesthesia Gas Machine

Manufacturer

Datex-ohmeda, Inc.

Model number

Catalog number

1012-9620-000

Lot number

Product problems

No Flow

Patient

Not reported

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

As a result of an inspection that was completed as part of the correction initiated by GE HealthCare (GEHC) on 02-APR-2025, (Recall numbers Z-1624-2025, Z-1625-2025, Z-1626-2025, Z-1627-2025, Z-1628-2025, Z-1629-2025, Z-1630-2025, Z-1631-2025, Z-1632-2025, Z-1633-2025, Z-1634-2025, Z-1635-2025, Z-1636-2025, Z-1637-2025, Z-1638-2025) this unit was identified as having an issue that prevents effective mechanical ventilation in Volume Control Ventilation (VCV) mode. There was no patient involvement.

Additional Manufacturer Narrative

GE HealthCare (GEHC) reported a field modification for an issue that prevents effective mechanical ventilation in Volume Control Ventilation (VCV) mode per 21 CFR 806 on 02-APR-2025. The FDA Recall numbers are: Z-1624-2025, Z-1625-2025, Z-1626-2025, Z-1627-2025, Z-1628-2025, Z-1629-2025, Z-1630-2025, Z-1631-2025, Z-1632-2025, Z-1633-2025, Z-1634-2025, Z-1635-2025, Z-1636-2025, Z-1637-2025, Z-1638-2025.Customers were sent a letter explaining the issue and providing instructions for inspecting for effective ventilation in Volume Control Ventilation (VCV) mode. GEHC will correct all devices that fail the Ventilation Screening Test at no cost.Block A: No patient involvement.Legal Manufacturer:HCS Madison - 3030 Ohmeda Dr, USA Madison, WI 53718.

Remedial action

Recall