Reported Mar 11, 2015 · Terminated
Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and…
Arjo Hospital Equipment AB
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: Arjo Hospital Equipment AB · HANS MICHELSENSGATAN 10 · Malm¿, N/A · N/A
Is this the product you have?
- Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications.
- Lot codes and dates
- SERIAL NUMBERS
226 of 226 codes
RRFK00041RRFK00083RRFK00232RRFK00233RRFK00276RRFK00229RRFK00215RRFK00221RRFK00243RRFK00121RRFK00263RRFK00094RRFK00150RRFK00274RRFK00103RRFK00198RRFK00256RRFK00111RRFK00290RRFK00091RRFK00044RRFK00087RRFK00241RRFK00047RRFK00186RRFK00059RRFK00170RRFK00246RRFK00064RRFK00071RRFK00289RRFK00056RRFK00078RRFK00178RRFK00051RRFK00248RRFK00155RRFK00202RRFK00247RRFK00128RRFK00228RRFK00269RRFK00126RRFK00277RRFK00207RRFK00253RRFK00067RRFK00280RRFK00108RRFK00174RRFK00161RRFK00105RRFK00125RRFK00240RRFK00052RRFK00102RRFK00147RRFK00153RRFK00082RRFK00062
- SERIAL NUMBERS
- Amount recalled
- 226 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
The recalled devices labeling and instructions for use contain unapproved medical claims.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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