Intuitive Surgical, Inc. recalls da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da Vinici X da Vinci Xi Sureform…
As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed distally within the jaws, rather than being held in place and transected.…
Read the official notice →- Date
- 2022-05-04
- Country
- United States
- Brand
- Intuitive Surgical
- Product
- da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da Vinici X da Vinci Xi Sureform…
- Classification
- Class II
- Units
- Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-08-10
USIntuitive 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 →- 2022-08-03
- US
Intuitive Surgical, Inc. recalls Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier,…
Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
FDA · DeviceIntuitive Surgical, Inc.Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK,…Official notice → - 2022-06-08
- US
Intuitive Surgical, Inc. recalls VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
FDA · DeviceIntuitive Surgical, Inc.Worldwide distribution - US Nationwide and the countries/regions of Argentina,…Official notice → - 2022-03-09
- US
Intuitive Surgical, Inc. recalls da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11
Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, additional surgery may be required to remove the metal tip. If the procedure proceeds without the metal tip, there is…
FDA · DeviceIntuitive Surgical, Inc.Worldwide distribution - US Nationwide distribution in the states of…Official notice → - 2022-01-05
- US
Intuitive Surgical, Inc. recalls da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605…
Issue was identified during internal engineering evaluation. Use of the system with the affected software version may experience either an inability to deliver energy or an inadvertent delivery of energy. Use may…
FDA · DeviceIntuitive Surgical, Inc.US Nationwide distribution in the states of Arizona, California, Connecticut,…Official notice → - 2021-12-01
- US
Intuitive Surgical, Inc. recalls The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision…
Incorrect expiration date on its package labeling (shipper box and inner carton label).
FDA · DeviceIntuitive Surgical, Inc.Worldwide distribution - U.S. Nationwide distribution in the states of AL, CA,…Official notice →
Other drugs & medical recalls in the United States
- 2022-05-04
- US
Boston Scientific Corporation recalls SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away from the…
Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps to verify correct…
- US
Sight Sciences, Inc. recalls TearCare version 1.0 SmartHubs
Ophthalmic devices distributed prior to the recently-obtained 510(k) clearance do not fall within the relevant 510(k) exemption and so their performance characteristics were not evaluated by the FDA prior to…
FDA · DeviceSight Sciences, Inc.US Nationwide distribution in the states of PA, CA, OH, AZ, CT, NC, GA, TN,…Official notice → - US
NeuMoDx Molecular Inc recalls NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays: NeuMoDx SARS CoV-2 Test…
Potential for false positive results for SARS-CoV-2 in identified lots of cartridges, when used in conjunction with assays containing SARS-CoV-2 targets (NeuMoDx" SARS-CoV-2 Test Strip Cat #300800 and NeuMoDx" Flu…
FDA · DeviceNeuMoDx Molecular IncWorldwide distribution - US Nationwide distribution in the states of OH, MO,…Official notice → - US
Medtronic Neuromodulation recalls MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1)…
There is a software anomaly with the InterStim X Clinician software application with results in the data entered in the Patient Information fields not e retained and a " Data Lost" notification being displayed.
FDA · DeviceMedtronic NeuromodulationUS Nationwide distribution in the states of FL, IL, WI, TX, CA, ND, NC, KY,…Official notice → - US
Siemens Medical Solutions USA, Inc recalls syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syngo.via…
Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide distribution - US Nationwide distribution in the states of AL, AR,…Official notice → - US
Baxter Healthcare Corporation recalls PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701
This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the patient Gain/Loss Limit or the Return Pressure Drop Limit…
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the countries of Mexico, Brazil,…Official notice →