Z-0037-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 11, 2023
- Initiation Date
- August 30, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
Product Description
API3200MD Mass Spectrometer, Part Number 4466230
Reason for Recall
In rare occasions, the combination of a leak of a highly flammable solvent at the ion source probe, and an electrical discharge may result in a flame on top of the probe and possible ejection of the electrode assembly from the probe. There is a risk to the patient/user, customer property, or environment because there is a potential for a health risk and property damage should the flame be left unattended. The failure causes a delay in patient results.
Distribution Pattern
US Nationwide.
Code Information
Serial Numbers: EQ230011907, EQ230021911, EQ230001901