FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: 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.
- Recall number
- Z-1505-2016
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- 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.
- Status
- Terminated
- Initiated
- 2016-03-04
- Posted
- not on file
- Terminated
- 2018-07-02
- Reason
- 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.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K090403"]
- PMA numbers
- not on file
- Product code
- KPS
- Firm FEI
- 1525965
- Firm city
- Cleveland
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28