Intuitive Surgical Recalls Fluorescence Imaging Procedure Kits for Missing Storage Info
Intuitive Surgical is recalling Fluorescence Imaging Procedure Kits because storage conditions for indocyanine green are missing from the packaging.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 hazard is a labeling omission regarding storage conditions that could lead to loss of fluorescence rather than direct injury, fitting the criteria for moderate severity.
Plain-English summary
Intuitive Surgical, Inc. is recalling 1,532 units of the Fluorescence Imaging Procedure Kit (PN 950156-02). These kits are designed for use with Firefly Fluorescence Imaging for the da Vinci Xi 4000 Surgical Systems. The products were distributed nationwide.
The recall was initiated because the storage conditions for indocyanine green (ICG) are not listed on the individual kit box, the six-kit box, or the shipping box. The source text notes that if heat were to damage the material, the result would be a loss of fluorescence.
Healthcare facilities and users should stop using these kits and contact Intuitive Surgical for instructions on how to proceed.
The recalled product
- Product
- Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Xi 4000 Surgical Systems. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the…
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 1,532
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)
- PN 950156-02
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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