| Class 2 Device Recall AutoSPECT Pro Software Application | |
Date Initiated by Firm | March 04, 2016 |
Create Date | April 15, 2016 |
Recall Status1 |
Terminated 3 on July 02, 2018 |
Recall Number | Z-1505-2016 |
Recall Event ID |
73776 |
510(K)Number | K090403 |
Product Classification |
System, tomography, computed, emission - Product Code KPS
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Product | Extended Brilliance Workspace NM Special Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH.
Provides software applications used to process, analyze, and display medical images/data. |
Code Information |
M/N 882488; S/N: 66565, 66586, 66589, 66670, 66681, 66672, 66644, 66888, 66374, 66371, 66305, 66824, 66261, 66356, 66059, 66056, 67027, 66248, 66590, 66240, 66097, 66268, 66555, 66500, 66754, 66469, 66411, 66252, 66263, 66307, 66311, 66310, 66306, 66259, 67054, 67000 & 67017. |
Recalling Firm/ Manufacturer |
Philips Medical Systems (Cleveland) Inc 595 Miner Rd Cleveland OH 44143-2131
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For Additional Information Contact | Ms. Holly Wright Lee 440-483-5777 |
Manufacturer Reason for Recall | 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. |
FDA Determined Cause 2 | Software design |
Action | On March 4, 2016, the firm sent an URGENT - Field Safety Notice Medical Device Correction letter to their customers. The letter identified the affected device, the reason for the recall, and under what circumstances the problem occurs. Customers are to contact Philips as described if they are unsure whether their gamma cameras supports the modes. The firm will implement the AutoSPECT Pro software upgrade and contact customers to schedule the appointment. If further assistance or support is needed, customers are to contact their local Philips representative. |
Quantity in Commerce | 37 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = KPS
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