In proceedings involving pacemakers that had been replaced based on manufacturer recommendations, the Bundesgerichtshof (Federal Court, Germany) asked the Court of Justice ("ECJ") whether the device may be classified as defective based solely on evidence that quality control checks on devices of the same model disclosed a potential defect. The ECJ held that when a medical device has a potential defect, it is possible to classify all products of the same model as defective, without showing the product is defective in each individual case.
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