CLASS II Device recall · Reported 5 Jun 2013 · FDA Enforcement Report
User Manual addendum, TORS for da Vinci Surgical System IS recalled
Intuitive Surgical is recalling User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. The recall was initiated on 24 Jan 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1424-2013
- FDA event ID
- 65094
- Recalling firm
- Intuitive Surgical, Sunnyvale, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jan 2013
- FDA classified
- 29 May 2013
- Reported
- 5 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 24 Jan 2013 | Recall initiated by company | |
| 29 May 2013 | Classified by FDA | +125 days |
| 5 Jun 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.
Product as listed by the FDA
User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual for Transoral Surgery (TORS) provided information to update and replace the Indications for Use and Representative uses section and add the section Warnings for Transoral Otolaryngology Surgery.
Where it was distributed
US Distribution Only
Questions about this recall
Is User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000 recalled?
Yes. Intuitive Surgical recalled User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000 on 24 Jan 2013. The recall is Class II and its status is Terminated. Recall number Z-1424-2013.
Why was it recalled?
Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.
Which lots are affected?
Model number 552002-01
Where was it sold?
US Distribution Only
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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