Arjo Rotoprone Therapy System Recalled for Unapproved Medical Claims
Arjo Hospital Equipment AB is recalling 226 Rotoprone Therapy Systems because their labeling and instructions for use contain unapproved medical claims.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the specific defect is a labeling error involving unapproved medical claims. No physical safety hazards, injuries, or illnesses are reported, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
Arjo Hospital Equipment AB is recalling 226 units of the Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system used for the treatment and prevention of pulmonary complications.
The recall was initiated because the labeling and instructions for use of the recalled devices contain unapproved medical claims. The affected units were distributed worldwide, including in the United States, Germany, Austria, France, Italy, India, the EU, Mexico, Switzerland, Canada, Saudi Arabia, Kuwait, the Middle East, China, Japan, and Qatar.
Healthcare facilities and consumers should check their inventory for the specific serial numbers listed in the recall notice. If a device is found, it should be removed from service and the manufacturer contacted for further instructions.
The recalled product
- Product
- Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications.
- Manufacturer
- Arjo Hospital Equipment AB
- Hazard
- Affected units
- 226
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- SERIAL NUMBERS: RRFK00041
- RRFK00083
- RRFK00232
- RRFK00233
- RRFK00276
- RRFK00229
- RRFK00215
- RRFK00221
- RRFK00243
- RRFK00121
- RRFK00263
- RRFK00094
- RRFK00150
- RRFK00274
- RRFK00103
- RRFK00198
- RRFK00256
- RRFK00111
- RRFK00290
- RRFK00091
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Arjo Hospital Equipment AB under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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