[Recalled] KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vi
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems. |
|---|---|
| Brand / manufacturer | Intuitive Surgical, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2104-2012 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 13 July 2012 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Intuitive Surgical, Inc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
- What is (1R,4S)-1,7,7-trimethyl-3-(4-methylbenzylidene)bicyclo[2.2.1]heptan-2-one (CAS 741687-98-9)? Safety, Regulation & EU/US/Canada Perspective | ProductGuru
- Healthiest Canned Fruit Options for a Nutritious Diet
- Fiction, Fantasy, and the Real-World Safety of Your Favorite Scent Ingredients
- Understanding Microwave Safe Symbols for Consumer Confidence and Safety at Home
- Is E413 Tragacanth Safe to Eat? What This Natural Gum Really Is
- How Long Can You Safely Freeze Milk and Keep Its Quality?