The Recall Desk
ModerateFDA (Devices)·Z-1949-2015·Announced 2015-07-08

Intuitive Surgical Recalls da Vinci Xi Instrument Arm Drapes

Intuitive Surgical is recalling da Vinci Xi Instrument Arm Drapes because a pinched drape may cause a 'Missing reload error' on the Vision Cart touchscreen.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a functional error (touchscreen message) rather than a direct physical hazard or reported injury, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Intuitive Surgical, Inc. is recalling 310 units of the Instrument Arm Drape, IS4000, 20 Pack, used on the da Vinci Xi Surgical System. The recall involves manufacturing lot numbers 470015-05 and 470015-06. The product was distributed nationwide in the United States and internationally to multiple countries including Australia, Austria, Belgium, and the United Kingdom.

The recall is issued to advise of an issue that may occur involving the combination of the da Vinci Xi Drapes and Xi instruments. Specifically, a pinched drape may cause a 'Missing reload error' message to appear on the Vision Cart touchscreen. This notification is a Field Safety Notification.

Healthcare facilities and users should check their inventory for the affected lot numbers and system numbers listed in the recall documentation. If the product is found, it should be removed from service and the manufacturer contacted for further instructions.

The recalled product

Product
INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical System. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Drapes
Hazard
Affected units
310

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)

  • Manufacturing lot numbers: 470015-05

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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