Recall / Withdrawal

Recall and Withdrawal are formal market surveillance measures to remove AI systems from the market when they do not comply with AI Act requirements or present unacceptable risks.

Definitions:

• Withdrawal: Any measure to prevent an AI system in the supply chain from being made available on the market
• Recall: Any measure to achieve the return of an AI system already made available to deployers

Triggers for Recall/Withdrawal:

• AI system presents a risk to health, safety, or fundamental rights
• Non-compliance with essential AI Act requirements
• Failure of corrective action to remedy non-compliance
• Serious incident caused by the AI system
• Market surveillance authority order

Procedure (Article 79):

1. Market surveillance authority identifies non-compliance or risk
2. Authority notifies the relevant economic operator (provider, importer, distributor)
3. Operator given opportunity to respond and take corrective action
4. If corrective action insufficient, authority orders withdrawal or recall
5. If the system poses serious risk, immediate action may be taken
6. Notification to other Member States through EU Rapid Alert System

Economic Operator Responsibilities:

• Cooperate with market surveillance authorities
• Inform other operators in the supply chain
• Notify affected deployers
• Bear costs of recall/withdrawal where responsible for non-compliance

Consequences of Non-Cooperation: Failure to comply with recall/withdrawal orders can result in administrative fines up to €15 million or 3% of global annual turnover.