SPiNPlanning Laptop Workstation SYS-0185Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00815686020033), received between Jun 6, 2022 and Jun 23, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Communication or Transmission Problem” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

12 other recalls cover devices cleared under the same FDA submission (K122106); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 10, 2023Open, Classified

   Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment

   Z-2659-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2023Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem; Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem

  A VERAN TERRITORY MANAGER/SALES REPRESENTATIVE WAS ON-SITE WHEN THE FOLLOWING EVENT OCCURRED. THE REPRESENTATIVE WAS UNABLE TO GET INTO THE VERAN LAPTOP, SYS-0185 (SPIN PLANNING LAPTOP WORKSTATION), DUE TO THE HOSPITAL'S INFORMATION TECHNOLOGY (IT) SECURITY/DOMAIN BLOCKING THE USERNAME AND PASSWORD FROM WORKING. IN ADDITION, THE HOSPITAL DID NOT ORDER AN IN-HOUSE COMPUTED TOMOGRAPHY (CT) SCAN FOR THE PATIENT BECAUSE THEY WERE PLANNING TO USE CT SCANS FROM ANOTHER FACILITY. THE HOSPITAL'S IT STAFF INFORMED THE VERAN REPRESENTATIVE THAT DUE TO THE LAPTOP NOT BEING USED AND NOT HAVING BEEN CHECKED IN ON THE HOSPITAL'S DOMAIN SECURITY SYSTEM IN OVER 60 DAYS, THE USERNAME AND PASSWORD WERE DEACTIVATED AS A SECURITY MEASURE. IN ADDITION, THE CT SCANS PROVIDED BY THE OTHER FACILITY WERE INSUFFICIENT FOR THE VERAN SCAN PROTOCOL PARAMETERS. ONCE THEY WERE ABLE TO LOG ON TO THE LAPTOP AND THE PATIENT WAS RE-SCANNED PER VERAN PROTOCOL, THE SCANS WERE ABLE TO BE UPLOADED TO THE LAPTOP AND THEY WERE ABLE TO PROCEED AND COLLECT SAMPLES, AS PLANNED. THERE WAS NO PATIENT INJURY OR IMPACT DUE TO THE ISSUES; HOWEVER, THE PATIENT WAS UNDER ANESTHESIA FOR AN ADDITIONAL 90 MINUTES WHILE THE IT ISSUES W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17191909 ↗
• InjuryJun 22, 2023Computer Operating System Problem; Computer Operating System Problem

  A VERAN REPRESENTATIVE WAS ON-SITE WHEN THE FOLLOWING EVENT OCCURRED. THE SYS-0185 (SPIN PLANNING LAPTOP WORKSTATION) WAS DESCRIBED AS RUNNING SLOW DURING A PROCEDURE. AFTER TROUBLESHOOTING STEPS WERE PERFORMED, IT WAS OBSERVED THAT THE CENTRAL PROCESSING UNIT (CPU) WAS FUNCTIONING AT A LOW PERCENTAGE. THE PROCEDURE WAS ABLE TO BE COMPLETED AFTER A 45-MINUTE DELAY. THERE WAS NO IMPACT ON THE PATIENT DUE TO THE EXTENDED PROCEDURE TIME. ALTHOUGH THERE WAS NO PATIENT INJURY OR IMPACT, THIS EVENT IS BEING REPORTED DUE TO THE 45-MINUTE DELAY WHILE THE PATIENT WAS UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17186946 ↗
• InjuryMay 19, 2023Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem; Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem

  A VERAN TERRITORY MANAGER/SALES REPRESENTATIVE WAS ON-SITE WHEN THE FOLLOWING EVENT OCCURRED. DURING THE CASE SET UP, THE SALES REPRESENTATIVE TRIED TO EXPORT THE PLAN FROM THE SYS-0185 (SPINPLANNING LAPTOP WORKSTATION) TO THE SYS-4000 (SPIN THORACIC NAVIGATION SYSTEM, 120V, 60HZ) OVER SPIN LINK, BUT THE SPIN LINK TRANSFER HAD A YELLOW CAUTION SYMBOL. TROUBLESHOOTING WAS PERFORMED WITH VERAN TECHNICAL SUPPORT (VSUPPORT), BUT THE SPIN LINK CONNECTION WOULD NOT WORK. THE SALES REPRESENTATIVE THEN TRIED TO TRANSFER THE PLAN OVER A UNIVERSAL SERIAL BUS (USB), BUT HE CONTINUED TO RECEIVE A MESSAGE THAT THE DATA COULD NOT BE UPLOADED. AFTER TRYING TWO MORE USB'S, THE SALES REPRESENTATIVE DISCOVERED THAT THE INFORMATION TECHNOLOGY (IT) DEPARTMENT AT THIS SITE BLOCKS USB USE, AND THAT A SPECIAL ENCRYPTED USB WAS NEEDED. THE DOCTOR DECIDED TO MOVE FORWARD WITH THE PROCEDURE USING FLUOROSCOPY, IN CONJUNCTION WITH THE ALREADY-PLANNED RADIAL ENDOBRONCHIAL ULTRASOUND (EBUS). THERE WAS A 1-HOUR DELAY DURING TROUBLESHOOTING, DURING WHICH THE PATIENT WAS UNDER ANESTHESIA. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. FURTHER FOLLOW-UP WAS PERFORMED, AND THE NURSE MANAGER CONFIRMED THERE WAS NO HARM TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16970374 ↗
• InjuryJun 6, 2022Application Program Problem

  VERAN REPRESENTATIVE ATTEMPTED TO EXPORT THE PROCEDURE PLAN FROM THE SPIN PLANNING WORKSTATION ONTO A USB AND IMPORT IT ONTO THE TOWER. THE PLAN WOULD NOT EXPORT. THE PATIENT WAS UNDER ANESTHESIA. THE PROCEDURE WAS DELAYED FOR 20 MINUTES AND THEN HAD TO BE ABORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14605334 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122106. One submission often covers many models, so check the product and lot details in each record.

• Z-2662-2023 · Aug 10, 2023 · Open, Classified
  Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SPiN Xtend 21ga, 1.8 OD, 5/Bx INS-5440 View Peripheral Catheter, 3.8mm OD, 2.5mm WC INS-5411 0.016
• Z-2663-2023 · Aug 10, 2023 · Open, Classified
  Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga INS-5039 Always-On vTrack Universal Tracker, SM/CL, 12-18ga INS-5036 "
• Z-2664-2023 · Aug 10, 2023 · Open, Classified
  Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx INS-0372 AOTT Serrated For
• Z-2661-2023 · Aug 10, 2023 · Open, Classified
  Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-5611 SPiN Perc Localization Needle - 2cm, 5/Bx INS-5610 SPiN
• Z-2263-2023 · May 15, 2023 · Open, Classified
  Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD, Oval Cup-Intended for use in clinical interventions and for anatomical structures where computed tomo
• Z-2265-2023 · May 15, 2023 · Open, Classified
  Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures whe
• Z-2266-2023 · May 15, 2023 · Open, Classified
  Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures wher
• Z-2269-2023 · May 15, 2023 · Open, Classified
  Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm OD, 21ga Intended for use in clinical interventions and for anatomical structures where computed tomogr
• Z-2262-2023 · May 15, 2023 · Open, Classified
  Always-On Tip Tracked Instruments (SPiN Drive instruments) Brush, 15mm L, 1.8mm OD Intended for use in clinical interventions and for anatomical structures where computed tomograph
• Z-2264-2023 · May 15, 2023 · Open, Classified
  Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8mm OD, Serrated Cup-Intended for use in clinical interventions and for anatomical structures where computed t
• Z-2268-2023 · May 15, 2023 · Open, Classified
  Always-On Tip Tracked Instruments (SPiN Drive instruments) 22ga SPiN Flex Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where co
• Z-2267-2023 · May 15, 2023 · Open, Classified
  Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where comp