GETINGE CM320-SERIES (REF CM320WU)Recalls & reported problems
Getinge Disinfection AB · CM320-2 CHAMBER WU. Washer disinfector with one Washer chamber followed by an Ultra-sonic washer chamber. · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07340153700185), received between Nov 3, 2023 and Nov 3, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Fell” (1 report).
2 FDA recall records name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Apr 13, 2022Open, Classified
Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip and fall injury. May lead to a patient procedural delay and/or infection
Z-1248-2022 · Root cause: Process control · FDA record ↗
- Dec 21, 2020Terminated
The potential that the plastic inlet hose connections may deform or break as a result of material fatigue and/or over tightening of the clamps. A broken hose connection may lead to a hazardous situation of water leakage or water spray. The water leakage or water spray may result in a burn to the user and/or an inconvenience due to a procedural delay if the Washer Disinfector is taken out of service.
Z-1124-2021 · Root cause: Device Design · FDA record ↗
Most reported problems
Device problems
- Device Fell1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 3, 2023Device Fell; Device Fell
MANUFACTURER'S REFERENCE NUMBER: (B)(4)
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18063075 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.