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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

631

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 9841–9860 of 10391 recalls

Hitachi Medical Systems America Inc: Magnetic Resonance Imaging Device

The device has a software anomaly which causes the operating system to 'lock up' and data to become corrupted during service procedures.

FDAFeb 21, 2006Nationwide• Hitachi Medical Systems America Inc

Bayer Healthcare, LLC (Diagnostics Division): ADVIA 1650 Chemistry System, Automated Clinical Chemistry...

Low QC recovery observed on carbamazepine (CARB) results immediately following a Gentamicin (GENT) assay or a Digoxin (DIG) assay. When GENT or DIG precedes CARB, the CARB test result is artificially low (as much as -25%). PHNY was determined to also exhibit a similar carryover effect on CARB. All others were found not to produce the same reagent probe-based carryover effect.

FDAFeb 17, 2006PR• Bayer Healthcare, LLC (Diagnostics Division)

Bayer Healthcare, LLC (Diagnostics Division): ADVIA 1200 Chemistry System, Automated Clinical Chemistry...

1...491 492493494 495...520

Page 493 of 520Next

FDAFeb 17, 2006PR• Bayer Healthcare, LLC (Diagnostics Division)

Depuy Mitek, a Johnson & Johnson Co.: Depuy Mitek Bioknotless Anchor with Ethibond Suture Ref N...

The inserter shafts bend, as they were manufactured with a different stainless steel than specified.

FDAFeb 17, 2006Nationwide• Depuy Mitek, a Johnson & Johnson Co.

Bayer Healthcare, LLC (Diagnostics Division): Advia 2400 Chemistry System, Automated Clinical Chemistry...

FDAFeb 17, 2006PR• Bayer Healthcare, LLC (Diagnostics Division)

Black Dog Hooded Sweatshirts (Black Dog Tavern) – Strangulation Risk (2006)

The recalled sweatshirts have a black dog on the front and are sold in youth sizes up to size 12, with drawstrings through the hood. Sweatshirt colors include navy blue, gray, red, pink, black or oatmeal. "The Black Dog," "Est. 71," or "The Black Dog/Martha's Vineyard" are printed on the back of some of the sweatshirts. A tag sewn on the inside of the garment reads, "The Black Dog." Style numbers are K086, K088, K090, K062, or K063 are printed on the garment's hang tag.

CPSCFeb 15, 2006Nationwide• The Black Dog Tavern Company Inc., of Vineyard Haven, Mass.

Baxter Healthcare Corp. Rt.: Baxter Auto Syringe AS40 and AS40A Infusion Pump, product...

The occlusion detection and alarm may be delayed when the pumps are used with larger volume syringes at low flow rates.

FDAFeb 8, 2006Nationwide• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Baxter Auto Syringe AS50 Infusion Pump, product code 1M85...

A non-conforming gasket was used in manufacturing of the specific pumps, causing the pumps to be more susceptible to electro-static discharge, which could increase the potential for the pump to fail during use and alarm.

FDAFeb 7, 2006Nationwide• Baxter Healthcare Corp. Rt.

Philips Medical Systems North America Co. Phillips: Allura Xper FD10/10 x-ray system

Potential lock-up of system requiring reboot of system.

FDAFeb 6, 2006Nationwide• Philips Medical Systems North America Co. Phillips

Philips Medical Systems North America Co. Phillips: Allura Xper FD10 x-ray system

Potential lock-up of system requiring reboot of system.

FDAFeb 6, 2006Nationwide• Philips Medical Systems North America Co. Phillips

Medtronic Inc. Cardiac Rhythm Managment: Medtronic Paceart 2004 Second Edition & Paceart 2005 Firs...

The Paceart System could inappropriately insert data from a patient's Medtronic CareLink transmission into another patient's Paceart record. An issue associated with the automated batch transfer of implanted cardiac device data from the Medtronic CareLink network to the Paceart System exists.

FDAFeb 2, 2006Nationwide• Medtronic Inc. Cardiac Rhythm Managment

Hitachi Medical Systems America Inc: Hitachi Altaire Magnetic Resonance Imaging System

Circuit Failure-There is the potential risk of the Phase Loss Detector Safety Device (PHSEN PCB) malfunctioning in the event of a power loss. The circuit may fail to turn off the system main breaker when 2 of the 3 power phases are lost.

FDAJan 27, 2006Nationwide• Hitachi Medical Systems America Inc

Bayer Healthcare, LLC (Diagnostics Division): Brand Name: RapidLab 1200 System, Model 1240, Part Number...

When stored data is recalled from memory, the results do not agree with the original results. Software anomaly: a calculation error occurs when using the correlation adjustment feature on the RapidLab 1200 Systems with software versions 1.0, 1.01, or 1.02. The correlation feature applies user-defined slope and offset parameters each time stored test results are recalled to the display.

FDAJan 20, 2006Nationwide• Bayer Healthcare, LLC (Diagnostics Division)

Shelhigh, Inc.: Shelhigh No-React Pulmonic Valve Conduit. **'Shelhigh N...

Unapproved Device-Distribution of an unapproved device into interstate commerce.

FDAJan 18, 2006AZ, MA• Shelhigh, Inc.

Stihl MS 192 T Chain Saws – Potential Defect (2006)

Fire/Burn Risk

The recalled Stihl-brand chain saws have model number MS 192 T, located on the side of the chain saw's starter housing. They include serial numbers 264371702 through 266087005, which is located on the top/front of the chain saw's housing.

CPSCJan 11, 2006Nationwide• Stihl Inc., of Virginia Beach, Va.

Mosquito Magnet Quick-Clear Valve – Maintenance Issue (2006)

The recall involves a maintenance accessory used to clear obstructions in the fuel delivery system of certain Mosquito Magnet® insect traps. The Quick-Clear Valve Adapter is a black and gold, "L"-shaped, brass and plastic device. The adapter was included as a maintenance accessory to clean fuel lines in newly manufactured and retrofitted Mosquito Magnet® insect traps sold only under the following Mosquito Magnet® model names: Defender, Liberty, Freedom and Commercial Pro. Only "L"-shaped adapters are affected by this recall. Mosquito Magnet® products made since November 2003 contain only straight adapters that do not need to be replaced. Adapters for Mosquito Magnet® traps that use rechargeable batteries are not affected by this recall.

CPSCJan 11, 2006Nationwide• American Biophysics Corp., of North Kingstown, R.I.

Baxter Healthcare Corp. Rt.: Baxter Epidural Anesthesia Trays that contain BD Catheter...

The BD catheter connector contained in the Epidural Anesthesia Trays may not fully secure the catheter and allows the catheter to either become loose or disconnected from the connector.

FDAJan 10, 2006Nationwide• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Baxter Continuous Epidural Anesthesia Trays that contain ...

The BD catheter connector contained in the Epidural Anesthesia Trays may not fully secure the catheter and allows the catheter to either become loose or disconnected from the connector.

FDAJan 10, 2006Nationwide• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Baxter Combined Epidural Anesthesia Trays that contain BD...

The BD catheter connector contained in the Epidural Anesthesia Trays may not fully secure the catheter and allows the catheter to either become loose or disconnected from the connector.

FDAJan 10, 2006Nationwide• Baxter Healthcare Corp. Rt.

Joerns Healthcare Inc.: Hoyer Hydraulic Patient Lifters model C-CB-L2, C-HLA, C-H...

A field correction is being conducted on select models of Hoyer Patient Lifts because of hydraulic jack problems that have resulted in patient injury. The possibility exists that the mounting stud located in the bottom of the hydraulic jack could become loose allowing the jack to disengage from the mast of the lift.

FDAJan 6, 2006Nationwide• Joerns Healthcare Inc.