FDA Device recall Z-2782-2015
Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems
- FDA Device
- Class II
- terminated
- Published 2015-09-23
On 2015-09-23 the FDA classified a Class II recall of Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems by Intuitive Surgical, citing B. Braun 2 gang 4-way stopcocks in the Fluorescence Imaging Procedure Kit may experience damage to the sterile packaging during shipping. The damage can result in tears to the pac….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2782-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-09 |
| Published | 2015-09-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Intuitive Surgical |
| Distribution | US |
Product
Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers: 950156-01, 950156-02, 950156-03. Product Usage: General and plastic surgery: The da Vinci Firefly Imaging system is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging.
Reason
B. Braun 2 gang 4-way stopcocks in the Fluorescence Imaging Procedure Kit may experience damage to the sterile packaging during shipping. The damage can result in tears to the packaging and has the potential to cause a breach in sterility of the supplied stopcocks.
Identifiers
| code_info | Product number: 950156-01: Lot numbers: NQ141201 NQ141502 NQ142201 NQ142901 NQ143201 NQ143301. Product number…Product number: 950156-01: Lot numbers: NQ141201 NQ141502 NQ142201 NQ142901 NQ143201 NQ143301. Product number 950156-02: Lot numbers: NQ143501 NQ143502 NQ143601 NQ143602 NQ143803 NQ143901 NQ143902. Product number 950156-03: Lot numbers : NQ144001 NQ150501 NQ143902 NQ150601 NQ143901 NQ150602 NQ143803 NQ150703 NQ143601 NQ150701 NQ143602 NQ150702 NQ144502 NQ150801 NQ144801 NQ150901 NQ145202 NQ150802 NQ144901 NQ151001 NQ145301 NQ151002 NQ145201 NQ151101 NQ150301 NQ150501 NQ144001. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2782-2015%22
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