Intuitive Surgical, Inc. recalls da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected…
Read the official notice →- Date
- 2023-07-12
- Country
- United States
- Brand
- Intuitive Surgical
- Product
- da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of PR, FL, MN, PA, AZ,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
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General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Intuitive Surgical recalls
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There is a potential that the robotic system's instrument cart arm may contain screws that may potentially fail which could result in uncontrolled motion of a catheter inside a patient's airways.
FDA · DeviceIntuitive Surgical, Inc.US Nationwide distribution in the states of AZ and CA.Official notice →- 2024-04-17
- US
Intuitive Surgical, Inc. recalls Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause the following, 1) Top Failure: internal tissue injuries,…
FDA · DeviceIntuitive Surgical, Inc.US: VA, CA, NH, FL, NY, CO, AL, KY, MD, NC, NJ, OH, SC, SD, TN, WA, WI, WV,…Official notice → - 2023-12-06
- US
Intuitive Surgical, Inc. recalls Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.
FDA · DeviceIntuitive Surgical, Inc.US: IL, FL, ID, SC, MI, TX, TN, NY, OR, CO, CA, MS, NJ, Puerto Rico OUS: South…Official notice → - 2023-04-05
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Intuitive Surgical, Inc. recalls da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.
FDA · DeviceIntuitive Surgical, Inc.U.S.: Cayman Islands, Dominican Republic, Puerto Rico, United States O.U.S.:…Official notice → - 2023-03-22
- US
Intuitive Surgical, Inc. recalls Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart,…
Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowing for uncontrolled…
FDA · DeviceIntuitive Surgical, Inc.Worldwide - US Nationwide distribution in the states of FL, GA, WA and the…Official notice → - 2022-12-07
- US
Intuitive Surgical, Inc. recalls INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray…
Potential staple deployment failure and device fragment generation
FDA · DeviceIntuitive Surgical, Inc.U.S.: Arizona, California, Colorado, Florida, Illinois, Indiana, Louisiana,…Official notice →
Other drugs & medical recalls in the United States
- 2023-07-12
- US
NeuroLogica Corporation recalls OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and…
1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and could lead to delay in patient treatment. 2.Batteries used to power the NL5000 device contain…
FDA · DeviceNeuroLogica CorporationWorldwide distribution - US Nationwide and the countries of Australia, Canada,…Official notice → - US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and…
Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)US Nationwide distribution in the states of AL, IL, IN, LA, GA, NV, TX.Official notice → - US
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. recalls Betta Link LG Reusable Fishmouth Guide-Intended for use in soft tissue to bone fixation in the repair of the natural…
Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.
FDA · DeviceT.A.G. MEDICAL PRODUCTS CORPORATION, LTD.Worldwide distribution - US Nationwide and the countries of Australia, Japan,…Official notice → - US
Full Vision Inc recalls TRACKMASTER, TREADMILL GE T2100-ST2 220V CHINA, MODEL NUMBER 317-07927GE CHINA
Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
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GE Healthcare Finland Oy recalls TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
- US
QUIDEL CARDIOVASCULAR INC recalls Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP, 97000HZ01,…
Raw material issue may cause cardiac panel products to have an average of 30% troponin signal reduction across measurement range 0.05 ng/mL to 30 ng/mL, QC testing won't detect anomaly, so an alternate method is…
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