Reported Aug 17, 2016 · Terminated
Ingenuity Core Model No. 728321; To produce cross-sectional images of the body.
Philips Medical Systems (Cleveland) Inc.
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: Philips Medical Systems (Cleveland) Inc · 595 Miner Rd · Cleveland, OH · 44143-2131
Is this the product you have?
- Ingenuity Core Model No. 728321; To produce cross-sectional images of the body.
- Lot codes and dates
- Ingenuity Core Model No. 728321
- S/N
314 of 314 codes
310015203052031520445205031029233306452000520125201552018520205202252063310001310022310023310026310032310039310096310105310133310135310157310160310209310210310211310212310213310214310215310216310217310218310219310220310221310222310223310224310225310226310227310228310229310230310231310232310233310234310236310237310238310239310240310241310242310243
- Amount recalled
- 276 Units
This recall covers 15 products
The agency filed one notice per product. You are reading one of them; the other 14 are below.
2 more are in the archive.
Where it was sold
Why it was recalled
Software issues in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 and Ingenuity CT products that could affect the performance of the equipment.
This product could cause temporary or reversible health problems — stop using it.
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