Class I - Dangerous
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
🔬
Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
Class I - Dangerous
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.
Complaints were received reporting the system would freeze/shut down while in Fulgurate mode.
Some anomalies have been identified during manufacturing controls.
Class I - Dangerous
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the LH 750, LH 780, LH 500 and HmX Analyzers may not flag or detect blasts in some blood samples.
The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the LH 750, LH 780, LH 500 and HmX Analyzers may not flag or detect blasts in some blood samples.
Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in affected systems.
FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
Class I - Dangerous
Customers have reported that some VITEK¿ 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards in subsequent carousel slots to be processed. The issue was reported to occur on VITEK¿ 2 Compact 15 and Compact 30 systems following a system software update to version 8.01.
Software defect
Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in affected systems.
Class I - Dangerous
When performing the Stitching function on GU60A system, unintended area is exposed to radiation
Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in affected systems.
Class I - Dangerous
Customers have reported that some VITEK¿ 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards in subsequent carousel slots to be processed. The issue was reported to occur on VITEK¿ 2 Compact 15 and Compact 30 systems following a system software update to version 8.01.
Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in affected systems.
Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in affected systems.