Accure PFMS00004Recalls & reported problems
Quanta System SPA · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
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
- Dec 6, 2023Open, Classified
Laser system's spot tracking system may become misaligned resulting in the possible risk of delivery of higher-than-expected laser energy to epidermal tissue, which may cause blistering.
Z-0778-2024 · Root cause: Use error · FDA record ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.