# China NMPA Product Recall - surgical lights

Source: https://www.globalkeysolutions.net/records/china_product_recall/berchtold-gmbh-co-kg/92fe762f-f108-49d1-a693-152cb9b4a5fc/
Source feed: China

> China NMPA product recall for surgical lights by BERCHTOLD GmbH & Co. KG published April 18, 2019. Recall level: Level 2 Recall. BERCHTOLD GmbH&Co.KG, a medical device manufacturer, in collaboration with its agent Stryker (Beijin

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: BERCHTOLD GmbH & Co. KG initiates recall of surgical lights
- Company Name: BERCHTOLD GmbH & Co. KG
- Publication Date: 2019-04-18
- Product Name: surgical lights
- Recall Level: Level 2 Recall
- Recall Reason: The manufacturer is aware that the aluminum cap portion of the Chromophare F528 and F628 lamp covers (manufactured between September 21, 2017 and November 13, 2018) has not fully cured the adhesive due to reduced sandblasting. This issue could lead to the risk of components detaching from the lamp cover. If these components detach, the lamp cover may fall off the lamp, causing temporary or reversible injury to doctors and/or patients.
- Discovering Company: Stryker (Beijing) Medical Devices Co., Ltd.
- Manufacturing Company: BERCHTOLD GmbH & Co. KG
- Summary: BERCHTOLD GmbH&Co.KG, a medical device manufacturer, in collaboration with its agent Stryker (Beijing) Medical Devices Co., Ltd., has initiated a voluntary Class II recall for specific surgical light models: Chromophare F528 and F628. This recall, reported to the National Medical Products Administration (NMPA) and publicized on April 18, 2019, addresses a manufacturing flaw in units produced between September 21, 2017, and November 13, 2018. The main issue stems from inadequate adhesive curing on the lamp covers, caused by reduced sandblasting during production. This defect presents a risk of internal components detaching, potentially leading to the lamp cover falling from the surgical light and causing temporary or reversible injury to medical staff or patients. Although 345 affected units were distributed in China, no related adverse events have been reported to date. Under the NMPA's regulatory guidelines, Stryker will inform customers and distributors, dispatch engineers for on-site inspections, and implement corrective actions. These actions include recall procedures and, if necessary, the replacement of faulty lampshades, which will then be destroyed. The affected surgical lights can continue to be used normally until these corrective measures are completed.

Company: https://www.globalkeysolutions.net/companies/berchtold-gmbh-co-kg/3ceeb682-de95-443a-b065-bd59a5d29110/