Ingenuity Core 128 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model No. 728323; S/N: 30153, 32001, 32002, 32003, 32004, 32005, 32006, 32007, 32009, 32011, 32012, 32014, 32017, 32019, 32020, 32022, 32023, 32024, 32025, 32027, 32028, 32029, 32030, 32031, 32035, 32038, 32039, 32040, 32041, 32046, 32048, 32052, 32053, 32058, 32059, 32060, 32065, 32066, 320124, 320128, 320135, 320136, 320137, 320139, 320140, 320141, 320142, 320143, 320145, 320148, 320149, 320150, 336030, 336031, 336032, 336033, 336034, 336035, 336036, 336037, 336038, 336039, 336040, 336042, 336043, 336045, 336047, 336048, 336049, 336050, 336051, 336052, 336053, 336055, 336056, 336057, 336058, 336063, 336065, 336069, 336074, 336701, 336702, 336703, 336704, 336705, 336706, 336707, 336708, 336709, 336710, 336711, 336712, 336713, 336714, 336715, 336716, 336717, 336718, 336719, 336720, 336721, 336722, 336723, 336724, 336725, 336726, 336727, 336728, 336729, 336730, 336731, 336732, 336733, 336734, 336735, 336736 & 336737.
- 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 Medical Systems (Cleveland) Inc
- Reason for Recall:
- The firm discovered Ring/Dot artifact due to X-ray measurement error.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Ingenuity Core 128 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Product Codes/Lot Numbers:
Model No. 728323; S/N: 30153, 32001, 32002, 32003, 32004, 32005, 32006, 32007, 32009, 32011, 32012, 32014, 32017, 32019, 32020, 32022, 32023, 32024, 32025, 32027, 32028, 32029, 32030, 32031, 32035, 32038, 32039, 32040, 32041, 32046, 32048, 32052, 32053, 32058, 32059, 32060, 32065, 32066, 320124, 320128, 320135, 320136, 320137, 320139, 320140, 320141, 320142, 320143, 320145, 320148, 320149, 320150, 336030, 336031, 336032, 336033, 336034, 336035, 336036, 336037, 336038, 336039, 336040, 336042, 336043, 336045, 336047, 336048, 336049, 336050, 336051, 336052, 336053, 336055, 336056, 336057, 336058, 336063, 336065, 336069, 336074, 336701, 336702, 336703, 336704, 336705, 336706, 336707, 336708, 336709, 336710, 336711, 336712, 336713, 336714, 336715, 336716, 336717, 336718, 336719, 336720, 336721, 336722, 336723, 336724, 336725, 336726, 336727, 336728, 336729, 336730, 336731, 336732, 336733, 336734, 336735, 336736 & 336737.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0176-2016
Related Recalls
Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Philips Medical Systems (Cleveland)
Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
Philips Medical Systems (Cleveland)
When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on the Edit Prescription screen.