# China NMPA Product Recall - X-ray computed tomography (CT) system

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/65d7134c-e52e-4d84-9b78-ce329d3d2c6a/
Source feed: China

> China NMPA product recall for X-ray computed tomography (CT) system by Philips Medical Systems published August 29, 2016. Recall level: Level III. Philips (China) Investment Co., Ltd., in conjunction with manufacturer Philips Medical Systems (Clev

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. voluntarily recalls X-ray computed tomography equipment.
- Company Name: Philips Medical Systems
- Publication Date: 2016-08-29
- Product Name: X-ray computed tomography (CT) system
- Recall Level: Level III
- Recall Reason: Philips has discovered a problem with the back cover of its scanning beds. The area around the Philips logo on the back subframe cover may not be strong enough to prevent cracking during normal operation. If the back cover is subjected to excessive force during contact with medical delivery equipment or accessories, it may crack, posing a potential risk of cuts or lacerations to unsuspecting operators, patients, caregivers, or service personnel. No injuries have been reported to date. (Internal Recall Document No.: CLE16-011)
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: Philips (China) Investment Co., Ltd., in conjunction with manufacturer Philips Medical Systems (Cleveland), Inc., initiated a voluntary Class III recall of specific X-ray Computed Tomography (CT) Systems. This recall was reported to the National Medical Products Administration (NMPA) on June 7, 2016, and publicly announced on August 29, 2016. The core issue centers on a defect in the back cover of the CT system's scanning table. Specifically, the area around the Philips logo on the back sub-frame cover may lack sufficient structural integrity, making it prone to cracking under normal operation or if subjected to excessive force from medical delivery equipment or accessories. This defect poses a potential risk of cuts or lacerations to operators, patients, caregivers, or service personnel. No injuries have been reported to date. In response, Philips has issued a Field Corrective Action (FCO) and directly notified all affected users. The company's field engineers are responsible for contacting customers to facilitate the replacement of the compromised back covers on all identified affected units, which include models such as Brilliance ICT and Ingenuity CTO.

Company: https://www.globalkeysolutions.net/companies/philips-medical-systems/91e33b43-88a2-4a53-9bcd-1d32f1abde47/