IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software recall
IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems, Cleveland, OH. Provides software applications used to…
Why was IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software recalled?
The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another. However, certain gamma cameras allow for other relative detector angles. Data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro and the results will likely be erroneous.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
M/N 881001; S/N: 85254, 82202, 85330, 82117, 7000022, 105009, 970001, 850001, 870030, 82141, 95068, 87182, 87197, 95078, 82140, 11017, 98139, 95035, 87200, 980047, 85314, 85303, 980046, 85298, 822022, 7000019, 950076, 950115, 95043, 95047, 950021, 960123 & 105006.
- Product
- IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems, Cleveland, OH. Provides software applications used to…
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 33 Units
- Distribution
- Worldwide Distribution -- US, including the states of CO, DE, FL, GA, IL, IN, KS, MO, NC, NV, NY, OH, OR, PA, TN & TX; and, the countries of Australia, Austria, Belgium, Canada, China, Denmark, Egypt, France, Germany, Greece, Ireland, Israel, Italy, Lebanon, Malaysia, Saudi Arabia, Slovenia, South Africa, Switzerland, Turkey, & United Kingdom.
- Recall date
- April 27, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)