WINGDERM ELECTRO-OPTICS LTD. recalls Non-ablative Fractional Laser Systems, Model: WFB-01
Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). All WFB-01 models sold to US customers found to have labeling non-compliances (22 units)
Read the official notice →- Date
- 2024-12-11
- Country
- United States
- Brand
- Wingderm Electro-Optics
- Product
- Non-ablative Fractional Laser Systems, Model: WFB-01
- Classification
- Class II
- Units
- Worldwide Distribution
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Wingderm Electro-Optics recalls
- 2024-12-11
USWINGDERM ELECTRO-OPTICS LTD. recalls Diode Laser Hair Removal model: WLA-01
All model WLA-01 systems sold to US customers are found to have labeling non-compliances
Other drugs & medical recalls in the United States
- 2024-12-11
- US
Smith & Nephew Inc. recalls BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
FDA · DeviceSmith & Nephew Inc.Worldwide - US Nationwide distribution in the states of AK, AL, IL, IN, KY,…Official notice → - US
Orthoscan, Inc. recalls Ziehm Solo. Digital Mobile C-arm
Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand…
- US
WINGDERM ELECTRO-OPTICS LTD. recalls Diode Laser Hair Removal model: WLA-01
All model WLA-01 systems sold to US customers are found to have labeling non-compliances
- US
Epilog Laser Corp. recalls Fusion Pro 24, Model 17000
a. A small number of Fusion Pro 24 units were released with an incorrectly placed Interlock device. As a result, the system can be operated with the front-loading door in an open position. b. Fails to comply with Class…
- US
Lannett Company Inc. recalls Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136,…
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
- US
Generitech Corporation recalls 10 Irregular Pigmentation, Accelerator, Pigment Fading Activator, Only Your Rx, Nature + Science, 1 fl. oz., 30 mL Bottle, For…
CGMP Deviations: Inconsistency in the water systems.