Intuitive Surgical Recalls Patient Side Cart Battery Boxes for Overheating Risk
Intuitive Surgical is recalling 2,606 Patient Side Cart Battery Boxes used with the da Vinci A surgical system because they may overheat and bulge during charging.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a risk of harm (overheating/bulging) without reported illness or injury falls under the 'Severe' category (Score 4), as it represents a significant potential hazard.
Plain-English summary
Intuitive Surgical, Inc. is recalling 2,606 Patient Side Cart Battery Boxes used in conjunction with the da Vinci A surgical system. The recall involves material number 371268-02, all lots, which were distributed worldwide.
The recall was initiated because the battery boxes may overheat in rare charging conditions, which can cause the batteries to bulge. This defect poses a potential safety risk to patients and medical staff using the surgical system.
Healthcare facilities and users should stop using the affected battery boxes immediately. Intuitive Surgical is the recalling firm responsible for managing this Class II recall.
The recalled product
- Product
- Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Intuitive Surgical Inc. Sunnyvale, CA 94086
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- Affected units
- 2,606
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Material number 371268-02 - al lots.
Distribution
Distribution scope not specified by the agency.
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