Reported Jan 21, 2015 · Terminated
iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer…
Brainlab AG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Brainlab AG · Kapellenstrasse 12 · Feldkirchen · N/A
Is this the product you have?
- iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.
- Lot codes and dates
56 of 56 products
Products covered by this recall # Product as published 1 21213 IPLAN RT DOSE 3.0 PLATFORM 2 21213A IPLAN RT DOSE 3.0.1 PLATFORM 3 21213B IPLAN RT DOSE 3.0.2 PLATFORM 4 21213D IPLAN RT DOSE 4.1.0 PLATFORM 5 21213E IPLAN RT DOSE 4.1.1 PLATFORM 6 21213F IPLAN RT DOSE 4.1.2 PLATFORM 7 21213G IPLAN RT DOSE 4.1.3 PLATFORM 8 21213H IPLAN RT DOSE 4.1.4 PLATFORM 9 21381 IPLAN RT DOSE 4.5.0 PLATFORM 10 21381A IPLAN RT DOSE 4.5.1 PLATFORM 11 21381B IPLAN RT DOSE 4.5.2 PLATFORM 12 21381C IPLAN RT DOSE 4.5.3 PLATFORM 13 21385 UPGRADE IPLAN RT DOSE 4.X TO 4.5.0 14 21385A UPGRADE IPLAN RT DOSE 4.X TO 4.5.1 15 21385B UPGRADE IPLAN RT DOSE 4.X TO 4.5.2 16 21385C UPGRADE IPLAN RT DOSE 4.X TO 4.5.3 17 21387 iPLAN RT DOSE PLATFORM 4.1 (21213) 18 21387A iPLAN RT DOSE PLATFORM 4.1.2 (21213) 19 21387B iPLAN RT DOSE PLATFORM 4.5.1 (21381) 20 21387C iPLAN RT DOSE PLATFORM 4.5.2 (21381) - Amount recalled
- 1412 systems total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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