# China NMPA Product Recall - X-ray computed tomography equipment

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systen-cleveland-inc/dca2e464-098d-47b9-82f1-7534df69637c/
Source feed: China

> China NMPA product recall for X-ray computed tomography equipment by Philips Medical Systen (Cleveland) Inc. published September 23, 2014. Recall level: . Philips Medical Systems (Cleveland), Inc., in collaboration with its Chinese distributor Philips (Ch

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Medical Systems (Cleveland), Inc. has recalled its X-ray computed tomography (CT) equipment.
- Company Name: Philips Medical Systen (Cleveland) Inc.
- Publication Date: 2014-09-23
- Product Name: X-ray computed tomography equipment
- Recall Reason: Philips learned through a customer complaint that during a CCT examination on the Ingenuity CT system, the first image (instead of the actual "last exposure") was marked as "last exposure." When the clinician pressed the pedal for the first exposure, the image displayed as "last exposure." Subsequent pedal presses failed to immediately reconstruct the image; the first image marked "last exposure" remained on the screen. Eventually, all images appeared. This issue was caused by an incorrect slice spacing setting in the CCT protocol user settings due to a protocol check card transition during software upgrades from v3.x to v4.0.0/v4.0.1. In normal CCT mode, image reconstruction is delayed, and the "last exposure" and the final reconstruction result are displayed correctly. To date, no injuries have been reported due to this issue. (Internal document number: FCO 72800620)
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systen (Cleveland) Inc.
- Summary: Philips Medical Systems (Cleveland), Inc., in collaboration with its Chinese distributor Philips (China) Investment Co., Ltd., initiated a voluntary recall of its X-ray Computed Tomography Equipment. The recall, reported on September 18, 2014, was overseen by the National Medical Products Administration (NMPA) of China. The core issue stemmed from incorrect slice spacing settings within the CCT protocol user settings, which occurred during a software upgrade from v3.x to v4.0.0/v4.0.1, attributed to a protocol check card conversion error. This defect caused the first image to be erroneously labeled as "last exposure" during CCT examinations, leading to delayed image reconstruction. While all images eventually appeared and no patient injuries were reported, the issue presented a potential operational concern. Notably, the affected product batches were not sold or imported into China. Despite no direct market impact, the NMPA proactively requested all provincial food and drug administrations to enhance supervision and management of similar products, reinforcing regulatory vigilance.

Company: https://www.globalkeysolutions.net/companies/philips-medical-systen-cleveland-inc/ed7d764b-6bff-4901-aefb-c49a08c8414f/