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…
Read the official notice →- Date
- 2023-03-22
- Country
- United States
- Brand
- Intuitive Surgical
- Product
- Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart, REF:…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of FL, GA, WA and the…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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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- Check the product name, strength and lot number against the official notice.
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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
- 2023-12-06
USIntuitive 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 →- 2023-07-12
- US
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…
FDA · DeviceIntuitive Surgical, Inc.Worldwide - US Nationwide distribution in the states of PR, FL, MN, PA, AZ,…Official notice → - 2023-04-05
- US
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 → - 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 → - 2022-11-02
- US
Intuitive Surgical, Inc. recalls da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision…
Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected to generator 3)…
FDA · DeviceIntuitive Surgical, Inc.US: MS, PA, WI, KY, TN, MI, FL, GA, NC, NV, LA, OH, IL, MO, IN, CA, AK, MD,…Official notice → - 2022-08-10
- US
Intuitive Surgical, Inc. recalls The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and X systems. The…
Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical unit designed to be used with the da Vinci Xi and X systems.
FDA · DeviceIntuitive Surgical, Inc.Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK,…Official notice →
Other drugs & medical recalls in the United States
- 2023-03-29
- US
- US
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by…
Defective Delivery System: Out of specification for shear.
- US
Boehringer Ingelheim Pharmaceuticals, Inc. recalls JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-0153-30) and b) 90-count (NDC…
Labeling: Label Mix-up
FDA · DrugBoehringer Ingelheim Pharmaceuticals, Inc.Product was distributed nationwide within the United States and PROfficial notice → - 2023-03-22
- US
Limacorporate S.p.A recalls TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.
- US
Bard Peripheral Vascular Inc recalls Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK
The external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle, which could lead to: 1) Procedural delay, 2) Requirement of an additional device, 3), Needle tip breakage, if…
FDA · DeviceBard Peripheral Vascular IncWorldwide Distribution: US (Nationwide) includes states of: FL, MD, OH, CO,…Official notice → - US
Brainlab AG recalls Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
FDA · DeviceBrainlab AGUS Nationwide distribution in the states of AZ, AR, CA, CO, FL, GA. IL, IN,…Official notice →