Z-1616-2010

Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner Compensation Coil. Part numbers: MR-FC-2EO, MR-FC-3EO

Name: Z-1616-2010 Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner Compensation Coil. Part numbers: MR-FC-2EO, MR-FC-3EO
Creator: Hitachi Medical Systems America Inc
Published: 2010-04-19
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2010-04-19 / Terminated

FDA source

Hitachi Medical Systems America Inc began a recall of Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner Compensation Coil. Part numbers: MR-FC-2EO, MR-FC-3EO on 2010-04-19. The reason FDA records is "Hitachi determined that the mounting method for a Compensation Coil did not include an appropriate factor of safety, so it is possible that the coil could fall, contacting the patient table and potentially putting a...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1616-2010
Status: Terminated
Initiated: 2010-04-19
Posted: 2010-05-19
Terminated: 2012-09-21
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner Compensation Coil. Part numbers: MR-FC-2EO, MR-FC-3EO
Product code: MOS Coil, Magnetic Resonance, Specialty
Reason for recall: Hitachi determined that the mounting method for a Compensation Coil did not include an appropriate factor of safety, so it is possible that the coil could fall, contacting the patient table and potentially putting a patient at risk.
FDA root cause: Other
Action: On 4/15/2010 the firm sent Device Correction Notice letters to their customers identifying the affected product and informing them of the potential problem. The letter stated that the firm will change the coil mounting method used at the customer's facility, if necessary, at no cost to the customer. A service rep will contact them to schedule a visit to correct the problem.
Quantity in commerce: 56 devices
Distribution: Nationwide Distribution -- AL, AR, AZ, CA, CT, DC, DE, FL, ID, IL, IN, KY, LA, MD, MO, NJ, NY, OH, OK, OR, RI, TN, TX, VA & WA.
Product codes and lots: Part numbers: MR-FC-2EO, MR-FC-3EO

Product code MOS

K001334Class IIHitachi Airis IIHitachi Medical Systems America, Inc. / cleared 2000-07-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)