intelerad IntelePACS software
INTELERAD MEDICAL SYSTEMS INCORPORATED · A cybersecurity vulnerability has been identified in the software that could allow a malicious user to take over an administrator session, delete or modify ima…
Open FDA's page for this record- Cfres ID
- 223113
- Product res number
- Z-0357-2027
- Event date initiated
- 2026-09-10
- Event date posted
- 2026-11-04
- Recall status
- Open, Classified
- Res event number
- 99971
- Product code
- LLZ
- Product description
- intelerad IntelePACS software
- Firm FEI number
- 3003768392
- Recalling firm
- INTELERAD MEDICAL SYSTEMS INCORPORATED
- Address 1
- 800, Boul. de Maisonneuve Est 800 Boul. de Maisonneuve Est
- Address 2
- 14th floor
- City
- Montreal
- Country
- Canada
- Root cause description
- Software Design Change
- Product quantity
- 560 software platforms
- Code info
HIBCC:B228INTELEPACS0/Affected versions: PACS-4-3-4-R20 PACS-4-9-1-R80 PACS-4-12-1-R81 through R90 PACS-4-14-1-R46 through R137 PACS-4-16-1-R50 through R137 PACS-4-17-1-R23 through R117 PACS-4-18-1-R31 through R91 PACS-5-1-1-R17 through R102 PACS-5-2-1-R36 through R93 PACS-5-3-1-R26 through R128 PACS-5-4-1-R15 through R101 PACS-5-5-1-R7 through R89 PACS-5-6-1-R12 through R81 PACS-5-7-1-R2 through R61 PACS-5-8-1-R2 through R42 PACS-5-9-1-R8 through R19
- Reason for recall
A cybersecurity vulnerability has been identified in the software that could allow a malicious user to take over an administrator session, delete or modify image or study data, or lock legitimate users out of the system. Additionally, a software issue has been identified that may result in the unintended deletion of image data from an external archive integration.
- Action
On September 15, 2026 Intelerad, (a GE HealthCare Company) issued a Urgent Medical Device Correction notification to affected consignees via: email. Intelerad ask consignees to take the following actions: 1. Pending corrections by Intelerad, you can continue to use your system by continuing to follow your organization's standard cybersecurity and access control practices until the corrective update is implemented. 2. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. 3. Please retain this document for your records. 4. Please complete and return the attached acknowledgement form electronically via FMI 88101 Digital Response Form or email, or print, fill out manually, scan, and email to Recall.88101@gehealthcare.com.
- Distribution pattern
US: AL FL CO MI CA TX CT AZ NJ IL NC SC MO NH WA KY WY DC NV IN PA AK OR AR KS TN MN MD IA WI HI NY OH VA WV NM GA LA NE UT WA OUS: Australia , Canada, Ireland, New Zealand, South Africa, United Kingdom
- K numbers
- K192176
- Harmonized identifiers (openFDA)
- Device name
- System, Image Processing, Radiological
- Medical specialty description
- Radiology
- Regulation number
- 892.2050
- Device class
- 2
- K number
- K080325, K071972, K140587, K992306, K002780, K974474, K063579, K844317, K143044, K192962, K022692, K103724, K191014, K883476, K080770, K212420, K083658, K130228, K142337, K072952, K033831, K080951, K083327, K000770, K130743, K130770, K033093, K180125, K053043, K123650, K063107, K914366, K092519, K110414, K173456, K243447, K073271, K170250, K180323, K223800 +2,257 more
- Registration number
- 3007301305, 3013665681, 3009196021, 2027467, 3025308066, 3013342228, 3018133052, 3005202320, 3033508292, 3006060685, 3017233423, 3011221136, 3013503781, 3009302839, 3011501361, 3036495186, 9680825, 3007339076, 3033527273, 3014498512, 3006260740, 3013634985, 3030409224, 3003989043, 3016244609, 3013718526, 2134213, 3006894636, 3010119782, 3004753388, 3022973841, 3019252669, 3010493171, 1825014, 3044622018, 3010533307, 3015961056, 3012448806, 3007487007, 3042625805 +603 more
- FEI number
- 3008581796, 3007301305, 3013665681, 3003772586, 3009196021, 2027467, 3002957361, 3025308066, 3013342228, 3018133052, 1000115748, 3005202320, 3033508292, 3006974930, 3004455125, 3006060685, 3017233423, 3011221136, 3013503781, 3009302839, 3011501361, 3001452787, 3036495186, 3007339076, 3033527273, 3014498512, 1000511585, 3006260740, 3013634985, 3030409224, 3003309342, 3003989043, 3016244609, 3013718526, 3006894636, 3010119782, 3004753388, 3022973841, 3019252669, 3010493171 +603 more