FDA Device recall Z-0078-2027
Spectral CT and Spectral CT 7500 RT
- FDA Device
- Class II
- ongoing
- Published 2026-10-14
On 2026-10-14 the FDA classified a Class II recall of Spectral CT and Spectral CT 7500 RT by Philips Medical Systems, citing software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0078-2027 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-21 |
| Published | 2026-10-14 |
| Last updated | 2026-10-21 05:30 UTC |
| Company | Philips Medical Systems |
| Distribution | US |
Product
Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.); Model Numbers: 1. 728333 (U.S. and Outside U.S.), 2. 728340 (Outside U.S.), 3. 728344 (Outside U.S.), 4. 728345 (Outside U.S.);
Reason
Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion.
Identifiers
| code_info | 1. Model Number: 728333 (U.S.); UDI-DI: 1. 00884838101111, 2. 00884838127876; Serial Numbers: 12055, 12054, 12052, 3980…1. Model Number: 728333 (U.S.); UDI-DI: 1. 00884838101111, 2. 00884838127876; Serial Numbers: 12055, 12054, 12052, 398006, 12044, 12045, 10237, 10056, 10194, 12059, 10278, 10319, 10143, 10081, 12047, 12048, 10198, 12046, 12043, 10262, 12042, 12041, 10186, 10241, 12039, 10317, 10316, 10264, 10127, 12038, 12037, 396014, 12036, 398005, 10016, 12034, 10076, 10074, 12035, 10021, 10018, 10023, 12032, 12029, 398003, 398004, 396013, 12027, 12026, 12023, 12025, 12024, 12021, 12022, 12017, 12019, 12018, 12020, 10312, 10311, 10310, 10305, 12016, 10308, 10306, 10307, 12014, 12013, 10304, 10302, 12012, 12011, 12010, 396012, 12007, 10301, 12009, 10300, 10299, 12008, 12006, 12005, 10298, 12002, 12003, 10294, 10292, 12001, 12000, 10293, 10290, 396011, 396010, 10291, 10289, 10279, 10288, 10287, 10284, 10286, 10281, 10285, 10271, 10276, 396009, 10280, 10275, 10273, 10277, 396008, 396006, 396007, 10274, 10272, 10270, 10269, 10252, 10154, 10268, 10267, 10261, 10266, 10265, 10219, 10263, 10260, 10157, 1025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-21 05:30 UTC. Current status: ongoing.
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FDA Device · Class II · 2026-08-05 · Philips Medical Systems - Philips Spectral CT on Rails
FDA Device · Class II · 2026-04-22 · Philips Medical Systems - Model: CT 5300
FDA Device · Class II · 2025-11-05 · Philips Medical Systems
All Philips Medical Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0078-2027%22
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