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…
Read the official notice →- Date
- 2022-01-05
- Country
- United States
- Brand
- Intuitive Surgical
- Product
- da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of Arizona, California, Connecticut,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
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
- 2022-08-03
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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.…
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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 → - 2021-12-01
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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 → - 2021-10-20
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Intuitive Surgical, Inc. recalls Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978
Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.
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Other drugs & medical recalls in the United States
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Biomerieux Inc recalls RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
There is an error in the new version of the package insert. The Reading Table lists the incorrect color for a negative result for the CIT test.
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Migo Trading LLC recalls FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
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Abbott recalls Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
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