Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are qualified to perform medical procedures on humans (having a maximum weight of 250 kg.) with probable internal diseases or injuries for: " Dedicated vascular and carotid imaging applications, including diagnostic and interventional procedures. " Cardiac imaging applications including diagnostics, interventional rocedures, pacemaker implantations and electrophysiology (EP). " Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.
Class I - DangerousWhat Should You Do?
- Check if you have this product: All serial numbers
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- Philips Electronics North America Corporation
- Reason for Recall:
- The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are qualified to perform medical procedures on humans (having a maximum weight of 250 kg.) with probable internal diseases or injuries for: " Dedicated vascular and carotid imaging applications, including diagnostic and interventional procedures. " Cardiac imaging applications including diagnostics, interventional rocedures, pacemaker implantations and electrophysiology (EP). " Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.
Product Codes/Lot Numbers:
All serial numbers
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0715-2016
Related Recalls
Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081
Philips Electronics North America
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