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Hitachi Medical Systems America Inc

Hitachi Medical Systems America Inc Recalls

All product recalls associated with Hitachi Medical Systems America Inc.

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Recall Summary

Total Recalls

1000

Past Year

353

Class I (Serious)

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 3321–3340 of 3680 recalls

Hitachi Medical Systems America Inc: Hitachi Altaire Magnetic Resonance Imaging Device.

Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder.

FDAJun 30, 2005Nationwide• Hitachi Medical Systems America Inc

Medtronic Emergency Response Systems, Inc.: LIFEPAK 20 defbrillator/monitor

The defibrillator may not operate if the device is turned on during an AC Loss Alert.

FDAJun 17, 2005Nationwide• Medtronic Emergency Response Systems, Inc.

BioHorizons Implant Systems Inc One Perimeter Park South: The Maestor System 225-312, Profile Abutment for Cement, 5mm

The product labeled as a profile abutment for Cement contained a Straight Permucosal Ext, 5mm x 3mm.

FDA

1...165 166167168 169...184

Page 167 of 184Next

Jun 3, 2005

MI, PA, TX +1 more

• BioHorizons Implant Systems Inc One Perimeter Park South

BioHorizons Implant Systems Inc One Perimeter Park South: The Maestro System 204-503, Straight Permucosal Ext, 5mm ...

The product labeled as a Straight Permucosal Ext, 5mm x 3mm contained a profile abutment for Cement.

FDAJun 3, 2005MI, PA, TX +1 more• BioHorizons Implant Systems Inc One Perimeter Park South

Plenum Network Cables (Hitachi Cable) – Installation Defect (2005)

Fire/Burn Risk

The recalled cables typically were installed in data centers and other commercial applications. The part numbers for the recalled cables are 39419-50 (25-pair, category 5e); 30171-100 (50-pair, category 5e); and 30105-50 (25-pair, category 5). Only HCM brand cables with the following lot numbers are affected by this recall: AE589 and A4309 through A5551. The part number and lot number are printed on the jacket of the cables.

CPSCMay 31, 2005Nationwide• Hitachi Cable Manchester (HCM), Inc. of Manchester, N.H.

Stryker Howmedica Osteonics Corp.: Triathlon Femoral Sizer - The Femoral sizer was developed...

Stryker Orthopaedics became aware that when attempting to position the Triathlon Femoral Sizer, the pre-setting may slip from l (left knee) to R (right knee) and vice verse intraoperatively.

FDAMay 27, 2005Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: The TRIO Spondylolisthesis Reduction Instrument is a Clas...

The threaded part of the instrument may break when connected to the screw and potentially result in an adverse health consequence.

FDAMay 16, 2005Nationwide• Stryker Howmedica Osteonics Corp.

Misys Healthcare Systems: Misys Laboratory with Lab Access Results application for ...

Software anomaly may rarely allow modification of previously reported specimen results.

FDAMay 13, 2005Nationwide• Misys Healthcare Systems

Misys Healthcare Systems: Mysis Laboratory version 6.1

When a previously reported microbiology organism result is deleted on a selected patient, reported susceptibilities will not stay with associated organisms and one or more suceptibilities on the culture will be deleted.

FDAMay 10, 2005Nationwide• Misys Healthcare Systems

Stryker Howmedica Osteonics Corp.: GMRS Extension Piece, 60 mm; Sterile Stryker Howmedica Os...

Mislabeled package: Package labeled as GMRS Extension Piece 60 mm, lot ZYCOC1 actually contains a GMRS Extension Piece 70 mm extension piece.

FDAMay 5, 2005Nationwide• Stryker Howmedica Osteonics Corp.

International Remote Imaging Systems Inc: IRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control T...

Nonconformance to performance specifications.

FDAApr 29, 2005Nationwide• International Remote Imaging Systems Inc

Philips Medical Systems North America Co. Phillips: View Forum 2003 software, SW 3.4L1

Automated analysis of vascular obstruction tool in software gives unreliable calibration and analysis results when using unprocessed images acquired on the Philips Allura FD10.

FDAApr 29, 2005Nationwide• Philips Medical Systems North America Co. Phillips

Philips Medical Systems: Philips Medical HeartStart MRx Monitor/Defibrillator Mode...

The device may disarm and not deliver shock when performing a Synchronized Cardioversion

FDAApr 29, 2005Nationwide• Philips Medical Systems

Stryker Howmedica Osteonics Corp.: Xcelerate Patella System Reamer Shaft Assembly; Non-Steri...

The Xcelerate Patella Reamer Shaft Assembly and the Reamer Adapter do not mate properly. This could result in the removal of excessive bone from the patella leading to a thinner patella; a patella that does not have enough bone for adequate engagement with pegs or patella fracture.

FDAApr 15, 2005Nationwide• Stryker Howmedica Osteonics Corp.

Varian Medical Systems: Flexible Implant tube, blind end, 350 mm, part # GM110037...

A defective treatment applicator in a cancer therapy medical device may become separated potentially causing patient injury.

FDAApr 14, 2005CO, CT, IN +4 more• Varian Medical Systems

Leica Microsystems, Inc.: Leica M520 Surgical Microscope; a surgical microscope wit...

Fire/Burn Risk

Patient Burns-The use of the surgical microscope at high light intensity and short working distances can result in patient burns.

FDAApr 12, 2005Nationwide• Leica Microsystems, Inc.

Hitachi Medical Systems America Inc: Altaire, Magnetic Resonance Imaging Device.

Fire/Burn Risk

The electrical cables that supply gradient power to the magnet can become loose over time and create a potential fire hazard.

FDAApr 11, 2005AL, AZ, AR +34 more• Hitachi Medical Systems America Inc

CTI PET Systems Inc: ECAT PET Scanners (mobile systems), distributed by Siemen...

Failure to properly secure the Mobile Bed Supports during transit could cause the support screws on the Patient Handling System to become loose and possibly break due to increased vibration during transit.

FDAApr 5, 2005Nationwide• CTI PET Systems Inc

Stryker Howmedica Osteonics Corp.: Allocraft TLIF Bone Inserter.

Stryker was made aware that the short arm of the bone inserter may fracture during use and potentially result in an adverse health consequence.

FDAApr 4, 2005Nationwide• Stryker Howmedica Osteonics Corp.

Varian Medical Systems Inc 3100 Hansen Way M/S E-210 Palo Alto CA 94304: Clinac (linear accelerator); Model 21EXS Silhouette Machi...

Emergency Off Switch located on the device may not function correctly resulting in the device remaining powered on after the switch is activated.

FDAMar 30, 2005CA, CT, IL +13 more• Varian Medical Systems Inc 3100 Hansen Way M/S E-210 Palo Alto CA 94304