Reported Mar 11, 2015 · Terminated
RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for…
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?
- RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications.
- Lot codes and dates
- SERIAL NUMBERS
260 of 260 codes
RRHK0012200157053RRHK00063RRHK00123001571820015721700157058RRHK000600015718400157346RRHK00110RRHK001190015737300157027001570740015722000157423001570880015730200157365RRHK00112RRHK00001RRHK00116RRHK0000300157200RRHK000141570300015746100157464001570890015730400157299RRHK0012100157264RRHK00071RRHK00007001572430015708600157432RRHK00067RRHK00097001571590015725800157362RRHK00118RRHK0009900157230RRHK000360015747100157013RRHK0001500157203RRHK00005001570140015735800157007001573440015716100157426RRHK00037
- SERIAL NUMBERS
- Amount recalled
- 271 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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