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: 14 Lot/code info: UDI-DI: 00842365100533; Serial Numbers: DE220001803PL, DE230011804, DE230031806, DE230041807, DE230051808, DE230071901, DE230081903, DE230091903, DE230162003, DE230272105, DE230292105, DE240002106, DE240022111, DE240042203
00842365100533
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.