Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1217-2015·Announced 2015-03-11

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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
Category: Medical Device — Patient Care System
Hazard: mis-labeling
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 →

Same manufacturer · Arjo Hospital Equipment AB

See all →

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Same hazard · mis labeling