# China NMPA Product Recall - Digital mammography machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/d5edf649-8d60-4bb8-a48f-7f70addd360c/
Source feed: China

> China NMPA product recall for Digital mammography machine by Philips Medical Systems published February 15, 2015. Recall level: Level 2. Philips (China) Investment Co., Ltd., representing manufacturer Philips Medical Systems DMC GmbH, in

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. voluntarily recalls digital mammography X-ray machines
- Company Name: Philips Medical Systems
- Publication Date: 2015-02-15
- Product Name: Digital mammography machine
- Recall Level: Level 2
- Recall Reason: Philips discovered an intermittent electronic defect through customer complaints and internal testing conducted in accordance with 21 CFR 1003.2(b)(1). In the MD Eleva system, software license keys are used to activate specific functions. In software versions R6.1.1 sp2 and R6.1.2, there were intermittent instances of missing license keys for certain software functions: the license key for the spectrometer filter and the license key for the entire bed tilt range. Without the license key for the spectrometer filter loaded, the low-dose mode of the reference air kerma rate did not decrease to 50% of the normal mode value, but should have been closer to 70% to 80%, resulting in a higher-than-expected patient dose. However, the low-dose mode is only intended for patient positioning, X-ray beam positioning, and/or situations where X-ray images have high contrast. For interventional procedures, the normal-dose mode is used for image quality requirements. Therefore, the higher-than-expected dose rate is only activated for short periods. Without the license key for the entire bed tilt range loaded, the bed tilt range was limited to -20° to 90° instead of the full -90° to 90° range. In this situation, not all required image mappings were feasible. These tilt positions were never used during critical phases of the inspection. To date, there have been only two customer complaints, and no injuries have been reported.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: Philips (China) Investment Co., Ltd., representing manufacturer Philips Medical Systems DMC GmbH, initiated a Class II voluntary recall for specific Digital Mammography Machines (MultiDiagnost Eleva FD, serial number 228). This action was reported to the National Medical Products Administration (NMPA) on January 21, 2015, after Philips identified intermittent software license key failures. The company's internal testing and customer complaints, handled in accordance with standards like 21 CFR 1003.2(b)(1), revealed two main issues. Firstly, the license key for the spectrometer filter occasionally failed to load, resulting in the low mode reference air kerma rate being higher than expected during patient positioning, potentially increasing patient dose for short durations. Secondly, the license key for the full bed tilt range intermittently failed, restricting the bed's movement from the intended -90° to 90° range to -20° to 90°, thereby preventing certain image mappings. Philips confirmed only two customer complaints and no reported injuries related to these malfunctions. As a corrective action, Philips will deploy field service engineers to install software version R6.1.3 on affected devices to resolve the license key loading issues.

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