Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · 6 months ago
Philips Achieva 1.5T Initial system with MR Elastography . 1 recall: The potential for stiffness value errors when a specific range of image
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm…
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Class II · 6 months ago
Medline medical procedure kits, containing Medline Neuro Sponges recall: During an internal review, Medline identified higher-than-expected endotoxin
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that…
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Class II · 6 months ago
Philips Ingenia 3.0T CX with MR Elastography . 1 recall: The potential for stiffness value errors when a specific range of image
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm…
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Class I · 6 months ago
WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05 recall: Cyber vulnerability of BLE communication was found by CISA VDP program
Cyber vulnerability of BLE communication was found by CISA VDP program.
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Class II · 6 months ago
Advanced Bionics, LLC Brand Name: HiResolution" Bionic Ear System Product Name: M recall: The non-tamperproof battery door supplied with the sound processor fails
The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to…
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Class II · 6 months ago
Philips Ingenia Elition X with MR Elastography . 1 recall: The potential for stiffness value errors when a specific range of image
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm…
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Class I · 6 months ago
North American Rescue LLC. Aidbags are first aid kits of convenience composed recall: Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood
Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design…
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Class II · 6 months ago
Philips Ingenia 1.5T CX with MR Elastography . 1 recall: The potential for stiffness value errors when a specific range of image
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm…
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Class II · 6 months ago
Philips Achieva 1.5T with MR Elastography . 1 recall: The potential for stiffness value errors when a specific range of image
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm…
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Class II · 6 months ago
Medline medical procedure kits, containing Medline Neuro Sponges recall: During an internal review, Medline identified higher-than-expected endotoxin
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that…
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Class II · 6 months ago
Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge recall: Includes an incorrect screw seat interface
Includes an incorrect screw seat interface.
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Class III · 6 months ago
Heraeus, Palamix duo. Material Number: 66057897 recall: Based on long-term stability testing, it was determined that in units older
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose…
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Class II · 6 months ago
Philips Ingenia Ambition S with MR Elastography . 1 recall: The potential for stiffness value errors when a specific range of image
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm…
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Class II · 6 months ago
Medline medical procedure kits, containing Medline Neuro Sponges recall: During an internal review, Medline identified higher-than-expected endotoxin
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that…
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Class II · 6 months ago
Medline medical procedure kits, containing Medline Neuro Sponges recall: During an internal review, Medline identified higher-than-expected endotoxin
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that…
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Class II · 6 months ago
Elekta, Inc. Brand Name: Leksell Vantage Arc System REF: 1053958 recall: Locking mechanisms may not properly secure to the Arc system
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
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Class II · 6 months ago
Medline medical procedure kits, containing Medline Neuro Sponges recall: During an internal review, Medline identified higher-than-expected endotoxin
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that…
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Class II · 6 months ago
Abbott Point Of Care Inc. i-STAT G3+ cartridge recall: Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number
Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number…
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Class II · 6 months ago
Medline medical procedure kits, containing Medline Neuro Sponges recall: During an internal review, Medline identified higher-than-expected endotoxin
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that…
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Class II · 6 months ago
Philips Evolution upgrade 3.0T with MR Elastography . 1 recall: The potential for stiffness value errors when a specific range of image
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm…
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Class II · 6 months ago
Medline Industries, LP Centurion medical convenience kits recall: Medline Industries, LP is issuing a recall for specific item(s) and lot(s)
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads…
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Class II · 6 months ago
Depuy Synthes, Attune Revision Hinge Femoral RT SZ 8 CEM recall: The external sterile packaging was found adhered to the internal sterile
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
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Class II · 6 months ago
Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158 recall: Includes an incorrect screw seat interface
Includes an incorrect screw seat interface.
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Class II · 6 months ago
Medline medical procedure kits, containing Medline Neuro Sponges recall: During an internal review, Medline identified higher-than-expected endotoxin
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that…