Arjo RotoRest Delta Therapy System Recalled for Unapproved Medical Claims
Arjo Hospital Equipment AB is recalling 271 RotoRest Delta Advanced Therapy Systems because their labeling contains 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 hazard is a labeling error (unapproved claims) rather than a physical defect causing injury or death. This aligns with the 'Moderate' criterion for minor labeling errors.
Plain-English summary
Arjo Hospital Equipment AB is recalling 271 units of the RotoRest Delta Advanced Therapy System. This medical device is designed to offer kinetic therapy for the treatment of pulmonary complications.
The recall was initiated because the device labeling and instructions for use 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 serial numbers against the list provided in the official recall notice to determine if their unit is affected. No specific corrective actions or consumer instructions are detailed in the provided source text beyond the identification of the defect.
The recalled product
- Product
- RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications.
- Manufacturer
- Arjo Hospital Equipment AB
- Category
- Medical Device — Therapy System
- Hazard
- Affected units
- 271
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: RRHK00122
- 00157053
- RRHK00063
- RRHK00123
- 00157182
- 00157217
- 00157058
- RRHK00060
- 00157184
- 00157346
- RRHK00110
- RRHK00119
- 00157373
- 00157027
- 00157074
- 00157220
- 00157423
- 00157088
- 00157302
- 00157365
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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