# China NMPA Product Recall - Guardian removal device

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/c323ea88-5451-4d61-a2a0-5ccf36f98f5b/
Source feed: China

> China NMPA product recall for Guardian removal device by Philips Medical Systems published December 12, 2014. Recall level: Level 2 Recall. Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall of its MRx monitored defi

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. voluntarily recalls patient-controlled defibrillators.
- Company Name: Philips Medical Systems
- Publication Date: 2014-12-12
- Product Name: Guardian removal device
- Recall Level: Level 2 Recall
- Recall Reason: Issue 1: When connected to AC or DC power, operated with a LAN cable, or near a power source prone to EFT interference, the MRx may be affected by electrical fast transient bursts (FETs), resulting in delayed or unexpected delivery. Issue 2: The MRx may exhibit unexpected performance if the user operates any of the following two non-standard clinical workflows. These workflows do not conform to the MRx Instruction of Use (IFU) and are not intended for use by trained clinicians. Workflow A: When defibrillating with an external defibrillator pad, the MRx may deliver a shock if the user presses only one of the two shock buttons in a specific sequence. Workflow B: When using the MRx with the Periodic Clinical Data Transfer (PCDT) option, the MRx may restart if the user performs the operation in a specific sequence. Issue 3: When the ECG electrode pads measure skin resistance contact impedance values outside the design range, the ECG lead may dislodge. Therefore, the MRx may stop on-demand pacing.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall of its MRx monitored defibrillator products (models M3535A, M3536A) on December 12, 2014, as reported by the National Medical Products Administration (NMPA). The recall addresses several critical issues impacting device performance. Firstly, the MRx device could experience treatment delays or unexpected energy delivery when exposed to Electrical Fast Transient Bursts (EFTs) from power sources or LAN connections. Secondly, specific non-standard clinical workflows, not outlined in the Instruction for Use, could lead to unintended device behavior, including an accidental shock delivery or device restart. Lastly, issues with ECG electrode pad impedance measurement could cause ECG lead detachment, potentially leading the MRx to stop on-demand pacing, particularly on devices with software version B.06.XX. In response, Philips is providing a free software upgrade for all affected devices. Company representatives will contact users to facilitate the installation of this essential software update.

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