IntelePACS, InteleConnect Portal/Tech Portal Versions PACS-5-1-1-R102, PACS-5-2-1-R93, PACS-5-3-1-R8
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The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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The recalled product
- Product
- IntelePACS, InteleConnect Portal/Tech Portal Versions PACS-5-1-1-R102, PACS-5-2-1-R93, PACS-5-3-1-R83 through R128, PACS-5-4-1-R66 through R101, PACS-5-5-1-R50 through R89, PACS-5-6-1-R41 through R81, PACS-5-7-1-R21 through R61, PACS-5-8-1-R2 through R42, PACS-5-9-1-R8 through…
- Manufacturer
- INTELERAD MEDICAL SYSTEMS INCORPORATED
- Category
- Medical Device — Devices
- Affected units
- 317
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Identifier Number PACS-5-1-1-R102
- HIBC Number +B228INTELEPACS0/$$75-1-1-R102C
- Identifier Number PACS-5-2-1-R93
- HIBC Number +B228INTELEPACS0/$$75-2-1-R93M
- Identifier Number PACS-5-3-1-R117
- HIBC Number +B228INTELEPACS0/$$75-3-1-R117K
- Identifier Number PACS-5-3-1-R128
- HIBC Number +B228INTELEPACS0/$$75-3-1-R128M
- Identifier Number PACS-5-3-1-R83
- HIBC Number +B228INTELEPACS0/$$75-3-1-R83M
- Identifier Number PACS-5-4-1-R101
- HIBC Number +B228INTELEPACS0/$$75-4-1-R101E
- Identifier Number PACS-5-4-1-R75
- HIBC Number +B228INTELEPACS0/$$75-4-1-R75O
- Identifier Number PACS-5-4-1-R82
- HIBC Number +B228INTELEPACS0/$$75-4-1-R82M
- Identifier Number PACS-5-4-1-R84
- HIBC Number +B228INTELEPACS0/$$75-4-1-R84O
- Identifier Number PACS-5-4-1-R91
- HIBC Number +B228INTELEPACS0/$$75-4-1-R91M
Distribution
Distributed nationwide across the United States.
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