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Acist Medical Systems

Acist Medical Systems Recalls

All product recalls associated with Acist Medical Systems.

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Recall Summary

Total Recalls

1000

Past Year

582

Class I (Serious)

Most Recent

Dec 2025

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 9181–9200 of 10937 recalls

Acist Medical Systems: ACIST CVi Angiographic Injection System with Interface Ca...

Multiple Injections may result. It has been determined that when using the ACIST CVi Angiographic Injection system to synchronize with the Toshiba Infinix -i cardiovascular x-ray system there is an injection scenario that may result in multiple injections of contract media when one injection was intended.

FDANov 10, 2008AZ, AR, FL +1 more• Acist Medical Systems

Merit Medical Systems, Inc.: ReSolve Hydrophilic Coated Locking Biliary Catheter, REF ...

Biliary drainage catheter tips may separate from the catheter shaft after placement.

FDANov 7, 2008Nationwide• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: ReSolve Hydophilic Coated Locking Biliary Catheter, REF R...

Biliary drainage catheter tips may separate from the catheter shaft after placement.

1...458 459460461 462...547

Page 460 of 547Next

FDA

Nov 7, 2008

Nationwide

• Merit Medical Systems, Inc.

Terumo Cardiovascular Systems Corporation: Terumo Advanced Perfusion System 1; 100V -120V, 15 A (cir...

The power manager board may cause a short circuit, resulting in loss of system power, loss of central control monitor or electrical arcing.

FDANov 7, 2008Nationwide• Terumo Cardiovascular Systems Corporation

Leica Microsystems, Inc.: QCA and iQCA software, a video microscopy software system...

A change in the software to open up the software architecture to include other analytes other than Estrogen Receptor was made without FDA review and approval.

FDANov 6, 2008Nationwide• Leica Microsystems, Inc.

Hitachi Medical Systems America Inc: Hitachi CXR4 Computed Tomography Scanner. This product is...

Software error: The device has a software error that can result in a condition where the displayed image orientation does not match the display orientation markers (right-left reversal).

FDANov 5, 2008Nationwide• Hitachi Medical Systems America Inc

GE Medical Systems, LLC: GE Innova 4100/4100 IQ. , GE Healthcare, Waukesha, WI 531...

One of three copper spectral filters could remain within the x-ray while the system displays no spectral filter. The displayed Air Kerma rate and thus cumulative Air Kerma are overestimated. The Air Kerma rate may be over estimated by up to 60%.

FDANov 4, 2008Nationwide• GE Medical Systems, LLC

GE Medical Systems, LLC: GE Healthcare Ventri, GE Healthcare, Waukesha, WI. Model ...

GE Healthcare become aware of an incident which caused a slight patient injury during his unload following a prone-oriented scan on Ventri. Although clear safety instructions were not followed in this case, additional measures will be implemented in an effort to reduce the probability or repeat occurrence.

FDANov 3, 2008AL, AZ, AR +35 more• GE Medical Systems, LLC

Medtronic Inc. Cardiac Rhythm Managment: Medtronic RV Lead Integrity Alert , Cat. # SW012, 1.0 sof...

Medtronic has identified an issue related to installation or removal of the Lead Integrity Alert software in EnTrust(R) and EnTrust(R) Escudo" defibrillators. In those devices only, installation or removal of LIA will inadvertently turn off two audible patient alerts.

FDANov 3, 2008AL, AK, AZ +48 more• Medtronic Inc. Cardiac Rhythm Managment

GE Medical Systems, LLC: Signa Openspeed 0.7T MR Systems, Model Numbers: Openspee...

GE Healthcare has identified a potential pinch point hazard on Ovation MR Scanner when using CTL Array XL Body Flex and Opened Body coil. A patient's hand may be pinched between the magnet bore ceiling cover and the CTL Array, XL Body Flex, or Open Body coil if the patient puts his/her hand on the top of the coil. Two injuries and four complaints filed. 2/20/09: Recall being expanded to incl

FDANov 3, 2008AL, AR, CA +36 more• GE Medical Systems, LLC

GE Medical Systems, LLC: GE Healthcare Signa Ovation 0.35T, Model Numbers: Ovation...

GE Healthcare has identified a potential pinch point hazard on Ovation MR Scanner when using CTL Array XL Body Flex and Opened Body coil. A patient's hand may be pinched between the magnet bore ceiling cover and the CTL Array, XL Body Flex, or Open Body coil if the patient puts his/her hand on the top of the coil. 2/20/09: Recall being expanded to include the OpenSpeed Systems.

FDANov 3, 2008AL, AR, CA +36 more• GE Medical Systems, LLC

Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK: Medtronic TSRH 3DX Implant Set; SPS002058. Sets are unla...

The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation.

FDAOct 31, 2008Nationwide• Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK

Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK: Medtronic TSRH Spinal System, 3Dx Splined Connector, Smal...

The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation.

FDAOct 31, 2008Nationwide• Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK

Cybex Treadmills – Fall Risk (2008)

This recall involves 115V ONLY Cybex 445T, 455T, 530T, 450T, 500T, 515T, 520T, and 550T treadmills. The 220V model treadmills are not involved in this recall. The treadmills are black and gray with rectangular uprights. The 530T style treadmill is 81 inches long by 32 inches wide. The 445T style treadmill is 72 inches long by 32 inches wide. The treadmills have a display panel on a console as wide as the treadmill. "Cybex" and the model number are written on the console.

CPSCOct 29, 2008Nationwide• Cybex International Inc., of Medway, Mass.

Serta Foam Core Mattresses – Flammability Violation (2008)

Fire/Burn Risk

The recalled mattresses have a zipper cover over a foam core. The mattresses were sold in twin, full, queen, king and California king sizes. They were manufactured between November 30, 2007 and May 20, 2008. The mattress name, date of manufacture, model, and serial numbers are located on label attached to the mattress. Only specific serial numbers are included in the recall. The recalled mattresses are listed in the chart below. Mattress Name Model Number Serene Signature Zip 810098, 810298, 810198, 810598 Accord Zip 830098 Perpetual Zip 830298, 830498 Solara Zip 830798 Solara II Zip 830898 Compass Zip 830198, 831598 Bellbrook Zip 830398 Elysian Zip 830698 Allington Zip 831098 Araceli Zip 831498 Royce Select Zip 831698 Contact Serta to determine if your serial number is included in the recall.

CPSCOct 28, 2008Nationwide• Serta International Mattress Co., of Hoffman Estates, Ill.

Duracell Notebook Power Adapters (Battery-Biz) – Burn Hazard (2008)

Fire/Burn Risk

This recall involves the Duracell 130W Combo AC/DC adapters with model numbers EA10900, AC-6501, and DRUM130 and date codes 0804 and 0805. The black power adapter is used with notebook computers. "DURACELL UNIVERSAL POWER ADAPTER" is printed on the front of the power adapter. The model and date codes can be found on the rating label on the back of the power adapter.

CPSCOct 28, 2008Nationwide• Battery-Biz Inc., of Camarillo, Calif.

Orthosoft, Inc. dba Zimmer CAS: Navitrack System - OS Knee Universal, Stereotaxic instrument

Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System OS Knee Universal software versions 2.2.0.82, 2.2.1.3, 2.1.6.0.2, D.54 and A.42 due to software issues resulting in erros and discrepancies .

FDAOct 28, 2008CA, FL, GA +13 more• Orthosoft, Inc. dba Zimmer CAS

Orthosoft, Inc. dba Zimmer CAS: Navitrack System - OS Knee Universal, Stereotaxic instrument

Class IIModerate

FDAOct 28, 2008CA, FL, GA +13 more• Orthosoft, Inc. dba Zimmer CAS

Intelerad Medical Systems Inc. 460 Ste-Catherine West Suite 210 Montreal Canada: IntelePACS Picture Archiving Communications System Intele...

Product software versions 3.5.2.P1 to 3.5.2.p56 inclusive and 3.6.1.P1 to 3.6.1.P82 inclusive were defective.

FDAOct 27, 2008Nationwide• Intelerad Medical Systems Inc. 460 Ste-Catherine West Suite 210 Montreal Canada

Philips Medical Systems North America Co. Phillips: Philips Allura XPER FD20 Angiographic X-ray system. This...

A high voltage reliability issue resulting in the loss of the x-ray generation and this can cause an intermittent stop of fluoro acquisition and exposure during an examination without warning and hence no image on the display.

FDAOct 23, 2008Nationwide• Philips Medical Systems North America Co. Phillips