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GE Healthcare, LLC

GE Healthcare, LLC Recalls

All product recalls associated with GE Healthcare, LLC.

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Recall Summary

Total Recalls

1000

Past Year

422

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 1921–1940 of 4598 recalls

GE Healthcare, LLC: Lunar iDXA bone densitometer

An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.

FDADec 3, 2019Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) ...

An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.

FDADec 3, 2019Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer

An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.

FDA

1...95 969798 99...230

Page 97 of 230Next

Dec 3, 2019

Nationwide

• GE Healthcare, LLC

Tri-Color Coleslaw (Dole) – Salmonella Risk (2019)

Salmonella

Canadian Food Inspection Agency reported finding Salmonella in a sample of Coleslaw with Green and Red Cabbage and Carrots.

Class IHigh

FDADec 2, 2019AK, CA, IN +4 more• Dole Fresh Vegetables Inc

AAP Implantate Ag Lorenzweg 5 Berlin Germany: aap Implantate AG, Soft tissue retractor, radiolucent, RE...

The company has become aware that the soft tissue retractor is not always removed during the sawing process. This can result in damage to the soft tissue retractor in which abrasion debris can develop and remain in vivo.

FDANov 28, 2019Nationwide• AAP Implantate Ag Lorenzweg 5 Berlin Germany

GE Healthcare, LLC: Carestation 620/650/650c A2 Product Usage: anesthesia ...

GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would cause a loss of mechanical ventilation and the system will provide high priority audio and visual alarms. Loss of mechanical ventilation could lead to hypoxia if the clinician does not intervene.

FDANov 25, 2019Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Carestation 620/650/650c A1 Product Usage: anesthesia ...

FDANov 25, 2019Nationwide• GE Healthcare, LLC

RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden: RayStation stand-alone software treatment planning system...

Editing a static arc beam may unexpectedly set the MU of the beam to its initial default value of 200 MU. If the bug is triggered, the dose is invalidated and needs to be recalculated before the plan can be approved or exported.

FDANov 18, 2019Nationwide• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

Nucletron BV Waardgelder 1 POBox 930 Veenendaal Netherlands: There is a complaint regarding internal check cable guide...

A component failure may lead to treatment interruption or incorrect source positioning.

FDANov 18, 2019Nationwide• Nucletron BV Waardgelder 1 POBox 930 Veenendaal Netherlands

GETINGE US SALES LLC: Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatri...

Sterile barrier system may be compromised

FDANov 13, 2019Nationwide• GETINGE US SALES LLC

GE Healthcare, LLC: ApexPro Telemetry System - Product Usage: The ApexPro Tel...

When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of the CARESCAPE Telemetry Server, ApexPro Telemetry Server, CARESCAPE Central Station (CSCS) version 1 and Central Information Center (CIC) systems were identified to have vulnerabilities to a cyber-attack.

FDANov 12, 2019Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: CARESCAPE Central Station - Product Usage: The intended u...

FDANov 12, 2019Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: CIC Pro Clinical Information Center Central Station - Pro...

FDANov 12, 2019Nationwide• GE Healthcare, LLC

MATRIX HEADGEAR ALPHA Equipment Recall: EQUIPMENT:MOTORCYCLE:HELMETS

Matrix Headgear LTD (Matrix) is recalling certain Alpha motorcycle helmets, in all sizes. The helmet retention system may fail, allowing the helmet to separate from the wearer's head in the event of a crash. Additionally, the helmet may not adequately protect the wearer in the event of a head impact during a crash. As such, these helmets fail to comply with the requirements of Federal Motor Vehicle Safety Standard (FMVSS) number 218, "Motorcycle Helmets."

NHTSANov 12, 2019Nationwide• MATRIX HEADGEAR

Ethicon Endo-Surgery Inc: Ligamax 5 mm Endoscopic Multiple Clip Applier

A potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the Tyvek lidding which could result in a breach of sterility.

FDANov 7, 2019Nationwide• Ethicon Endo-Surgery Inc

Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany: ARCHITECT HAVAB-G Calibrator, REF 6L27-01

Abbott has identified that Calibrator lot 08219BE00 is potentially impacted by an increase in Relative Light Units (RLUs) up to 94%. It has been confirmed that the increase in the calibrator RLU values may cause a decrease in the control values and patient results. Patient values generated using the impacted calibrator lot 08219BE00 may have changed interpretation from reactive to falsely non reactive. Results impacted may present as a (falsely) non reactive result that fall in the range between 0.50 to 0.99 S/CO.

FDANov 7, 2019AZ, CA, CO +20 more• Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany

FlipStix Knitting Needles (Skacel) – Laceration Risk (2019)

Laceration Risk

This recall involves US 6 (4.0mm diameter) FlipStix in 6" and 8" long knitting needles. The knitting needles have aluminum shafts that are tapered at both ends. The long shaft holds the active (unsecured) stitches of the fabric, to prevent them from unravelling, whereas the tapered ends are used to form new stitches. The knitting needles were sold in blue, red and yellow combination packages. There are five needles per pack.

CPSCNov 6, 2019Nationwide• Gustav Selter GmbH Co. & KG, of Germany

Qualigen Inc: The FastPack System Comlete Immunoassay Kit Immunoassa...

The chemiluminescent immunoassay has been noted to have higher than expected results which may result in inaccurate quantitative determinations of Sex Hormone Binding Globulin in human serum and plasma.

FDANov 6, 2019Nationwide• Qualigen Inc

Collagen Matrix Inc: GIBSON Healthcare Membrane Extended, 15mm x 20mm, Referen...

The products may have been packaged with an incorrect Instructions for Use.

FDANov 5, 2019Nationwide• Collagen Matrix Inc

MERRITT ANGEL GUARD ANGEL RIDE Child Seat Recall: CHILD SEAT:HARNESS:STRAP/WEBBING

Merritt Manufacturing Inc. (Merritt) is recalling certain Angel Guard Angel Ride car beds. The restraint harness may not have been properly sewed where the buckle is attached.

NHTSANov 5, 2019Nationwide• MERRITT ANGEL GUARD