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.
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: US Nationwide. Quantity: 10 Lot/code info: UDI-DI: 00842365100540; Serial Numbers: DD250051901, DD250172009, DD250182009, DD230001804, DD250111910, DD250132004, DD250091909, DD250101910, DD250192010, CN10011707PT
00842365100540
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.