Philips voluntarily recalls fetal monitors | Not sold in China
Medical Network September 13th The State Drug Administration announced today that Philips Investment Co., Ltd. reported that because the product print head is not fixed in the correct position, the recorder may have error deviation when printing tracking data, Philips Medizin Systeme Boeblingen GmbH took the initiative to recall the fetal monitor (Registration No.: National Machinery Note 20153213193). The recall level is three.
According to the Medical Device Recall Report Form, the fetal monitor is produced by Philips Medizin Systeme Boeblingen GmbH, Philips (China) Investment Co., Ltd. proxy.
The recalled fetal monitors were not sold in China, mainly involving Spain, Germany, the United States, and Belgium.
The main reason is recalled product lot: assembling errors due to assembly work, the print head is fixed on the correct position, resulting in printing the recorder trace data may have errors and deviations due to the known apparatus shown in paper printed value. Not the same, so this question is easy to find.
Attached: medical instruments Recall event report form