Devices

AIRIS II, Altaire Magnetic Resonance Imaging Devices

Model / Serial
Serial Numbers: Altaire - L217, L219, L221, L224 and L225; AIRIS II - C686-C688* [*The AIRIS units remained in Hitachi's inventory and were not distributed].
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
The devices were distributed to five (5) customers located in four (4)states: Colorado, Ohio, Nebraska and Texas
Product Description
AIRIS II, Altaire Nuclear Magnetic Resonance Imaging Device Systems
Manufacturer
Hitachi Medical Systems America Inc
1 Event
- Recall of AIRIS II, Altaire Magnetic Resonance Imaging Devices

Manufacturer

Hitachi Medical Systems America Inc

Manufacturer Address
Hitachi Medical Systems America Inc, 1959 Summit Commerce Park, Twinsburg OH 44087-2371
Manufacturer Parent Company (2017)
Hitachi Ltd
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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