Z-2782-2015Class II

Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers...

Name: Z-2782-2015 Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers...
Creator: Intuitive Surgical, Inc.
Published: 2015-09-09
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2015-09-09 / Terminated / root cause: packaging

FDA source

Intuitive Surgical, Inc. began a recall of 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... on 2015-09-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2782-2015
Classification: Class II
Status: Terminated
Initiated: 2015-09-09
Posted: 2015-09-17
Terminated: 2015-11-02
Recalling firm: Intuitive Surgical, Inc.
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.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: 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.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Intuitive sent an Urgent Medical Device Correction letters dated September 9, 2015 to all customers via traceable method. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to : 1. Ensure that all affected personnel are fully informed of this notice. Forward this notice to your Risk Manager, OR Director, Purchasing Manager, Biomedical Engineering staff, anesthesiologist and members of your medical staff who perform da Vinci Surgery procedures. 2. Prior to use, open and inspect current supply of Fluorescence Imaging Procedure Kits. If kits include B. Braun stopcocks, discard stopcocks and replace with other stopcocks 3. Continue to perform procedures using other stopcocks 4. Continue to follow directions provided in Florescence Imaging Procedure Kit IFU (p/n 550976), If a sterile item in a Fluorescence Imaging Procedure Kit becomes compromised in any way, do not use the compromised item; replace it with a new item. 5. Complete and return the attached Acknowledgment Form to Intuitive Surgical using the instructions provided. 6. Please retain a copy of this notice near your Fluorescence Imaging Procedure Kit inventory. Questions or concerns should be directed to Clinical Sales Representative or contact Intuitive Surgical Customer Service at the numbers listed below: " (800) 876-1310, Option 3 (6 AM to 5 PM PST) or mail: [email protected]
Quantity in commerce: 1200 kits
Distribution: US Nationwide Distribution
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2782-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2782-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-23	2015-09-17

Product code NAY

K141077Class IIDa Vinci Firefly Imaging SystemIntuitive Surgical, Inc. / cleared 2014-08-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)