Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Xi 4000 Surgical
FDA device recall Z-0835-2015 · posted 2014-12-19 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging Procedure Kit box, the six-kit box, and the shipping box. If heat were to damage the material, the result would be a loss of fluorescence.
- Action taken
- Urgent Medical Device Correction Letters were sent to customers on November 24, 2014.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 1532
- Distribution
- Nationwide Distribution.
- Date initiated
- 2014-11-21
- Date posted
- 2014-12-19
- Date terminated
- 2015-02-20
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DA VINCI FIREFLY IMAGING SYSTEM (K141077) | Intuitive Surgical, Inc. | 2014-08-12 |