🔍 RecallPedia

VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD568811911 ARD568811951, ARD568811961 The device is designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. These surgical lights may be installed in surgical suites, examining rooms, doctors' surgeries and outpatient consultations.

Class I - Dangerous
🏥 Medical Devices Recalled: February 7, 2018 GETINGE US SALES Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Model VLT600 SF AIM STP: Ref Code: ARD568811901: Serial Numbers: 21001 21002 22000 Ref Code: ARD568811911: Serial Numbers: 25002 31000 31001 31002 31003 31004 31006 31008 31009 31010 31012 31017 31018 31019 31020 31021 31022 31023 31024 31025 31026 35000 35001 35011 35012 35013 35014 35015 35017 35018 35019 35020 35021 35022 35023 35024 35025 35026 35027 35028 35029 35030 35031 35032 35033 38000 38001 38002 38003 38005 38009 38011 38012 38013 38014 38015 38016 38017 38018 38019 38020 38021 38022 38023 38024 38025 38026 38027 500000 500001 500002 500003 500004 500005 Model VLT600 DF AIM STP: Ref Code: ARD568811951 (Not in distribution in the U.S.) Serial Numbers: 20502 20503 Ref Code: ARD568811961 Serial Numbers: 25005 25006 25007 28003 28004 31000 31001 31002 31003 31004 31005 31006 31008 31009 31011 31012 31013 31014 31015 31016 31017 31019 31020 31030 31031 31039 31040 31041 31042 31043 31044 31045 31046 31047 31048 31049 31050 31051 31052 31053 31054 31055 31056 38025 38026 38027 38028 500001 500002
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
GETINGE US SALES LLC
Reason for Recall:
The manufacturer received complaints indicating that the device's central handle holder detaches easily from the handle holder ring on the light head during clinical use. In the event of such detachment, particles from the handle holder ring could fall into the sterile field during a procedure.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD568811911 ARD568811951, ARD568811961 The device is designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. These surgical lights may be installed in surgical suites, examining rooms, doctors' surgeries and outpatient consultations.

Product Codes/Lot Numbers:

Model VLT600 SF AIM STP: Ref Code: ARD568811901: Serial Numbers: 21001 21002 22000 Ref Code: ARD568811911: Serial Numbers: 25002 31000 31001 31002 31003 31004 31006 31008 31009 31010 31012 31017 31018 31019 31020 31021 31022 31023 31024 31025 31026 35000 35001 35011 35012 35013 35014 35015 35017 35018 35019 35020 35021 35022 35023 35024 35025 35026 35027 35028 35029 35030 35031 35032 35033 38000 38001 38002 38003 38005 38009 38011 38012 38013 38014 38015 38016 38017 38018 38019 38020 38021 38022 38023 38024 38025 38026 38027 500000 500001 500002 500003 500004 500005 Model VLT600 DF AIM STP: Ref Code: ARD568811951 (Not in distribution in the U.S.) Serial Numbers: 20502 20503 Ref Code: ARD568811961 Serial Numbers: 25005 25006 25007 28003 28004 31000 31001 31002 31003 31004 31005 31006 31008 31009 31011 31012 31013 31014 31015 31016 31017 31019 31020 31030 31031 31039 31040 31041 31042 31043 31044 31045 31046 31047 31048 31049 31050 31051 31052 31053 31054 31055 31056 38025 38026 38027 38028 500001 500002

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1349-2018

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GETINGE US SALES

Class I - Dangerous

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