Reported Jul 25, 2018 · Terminated
Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produce and deliver proton…
Fx Solutions
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: Fx Solutions · 1663 Rue de Majornas · Viriat Rhone-Alpes · N/A
Is this the product you have?
- Fx SOLUTIONS CENTERED HEAD CoCr 50x19
- REF 106-5019 Product UsageDevice is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck
- Lot codes and dates
- UDI03701037300435
- Lot Numbers
K238K240K689RK1119K1120K1121K1844L1730L1737L1748L1756L1764L1820
- M1042 OUS only
K237K239
- Amount recalled
- 131 units
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
- Nationwide
Why it was recalled
Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.
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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