Patient Side Cart recall
Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart, REF: 380652…
Why was Patient Side Cart recalled?
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 carriage movement along the insertion axis, which may cause tissue injury.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
System REF: Serial Numbers/Cart REF/UDI-DI/Arm Serial Numbers: IS4200: SL0379, SL0069/ 380620/ 00886874115404/ 668080, 575093, IS4000: SK1402, SK0991, SK2332, SK0744, SK0110, SK0753/380652 / 00886874110720/ 372054, 663693, 557322, 547953, 425439, 409962
- 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: 380652…
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 9
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, GA, WA and the countries of United Kingdom, Germany, France
- Recall date
- March 22, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)