Hitachi

L001 thru L223.

Radiology Devices

2

No

Nationwide-The device was distributed to consignees located throughout the United States.

Hitachi Altaire Magnetic Resonance Imaging System

Serial Number: CXR46201-46213 PC 46002-36011

Radiology Devices

2

No

The recalled MRI systems were distributed throughout the continental United States.

Hitachi CXR-4 CT Computed Tomography X-ray System (including SceptreP3 PET/CT)

Lots L33 through L50 through L99 and all M series lots.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide.

Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi models 717,747, 902, 911,912, 917, Modular and cobas c 501 clinical chemistry analyzers; Roche Catalog/Part Number 10825441001/ US # 722-4402.

Lots I90, I93 and I95 (alpha I and two digits)

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide.

Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi models 717,747, 902, 911,912, 917, Modular and Cobas c 501clinical chemistry analyzers; Roche Catalog/Part Number 10825441001/ US # 722-4402.