How do I get a refund or replacement for this recall?

Stop using the recalled product immediately. Follow the manufacturer's instructions on the official recall notice for returning or disposing of the product. Depending on the recall, you may receive a full refund, a replacement product, or a free repair. Visit the official source link on this page for claim instructions.

How do I know if my product is affected by this recall?

Check the product name, model number, lot number, or purchase date against the official recall notice. The official source link on this page contains the full list of affected units. If in doubt, stop using the product and contact the manufacturer directly.

Product Recalls & Refunds Online / National

Spectranetics Corporation: Philips Laser System, . Used in minimally invasive

Reward FDA device recall — free correction, repair, or replacement from manufacturer or authorized retailer

Recall reason: Laser System may detect Error 106 or Error 108 System Failures that will cause the system to enter non-recoverable safe state. The user will not be able to proceed until the error is cleared. May result in initiation of treatment delay and/or treatment beyond initial scope and/or unable to treat patient.. Recalled by Spectranetics Corporation. Distribution: US: LA, MO, TN, CA, NC, PA, HI, AZ, CO, OK, FL, TX, MN, MI, VA, CT, NY, MD, IL, NJ, MA, KS, ME, AR, IA, IN, GA, ID, OR. OUS: DE, GB, ES, SE, IT, RS, GR, IN, FR, IL, DK, SA. Classification (Class II — potential health risk). Affected lots/dates: UDI-00813132027452, Software Version: 0.5.0.3, Serial Numbers: 100000, 100001,

Reward FDA device recall — free correction, repair, or replacement from manufacturer or authorized retailer

Category Product Recalls & Refunds

Location National

Eligibility U.S. consumers who own or purchased the recalled medical device. Contact the manufacturer or the retailer/pharmacy where you purchased it to arrange for a free correction, repair, or replacement. Have the model number ready if possible.

Source Official Source ↗

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