# China NMPA Product Recall - electric wheelchair

Source: https://www.globalkeysolutions.net/records/china_product_recall/wenan-county-wantong-medical-equipment-co-ltd/dab8f21c-f784-4614-b830-d09721d7a7fb/
Source feed: China

> China NMPA product recall for electric wheelchair by Wen"an County Wantong Medical Equipment Co., Ltd. published December 31, 2020. Recall level: Level 3. Wen'an County Wantong Medical Device Co., Ltd. initiated a Level III voluntary recall of 63 units of

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Wen'an County Wantong Medical Device Co., Ltd. Product Voluntary Recall Notice
- Company Name: Wen"an County Wantong Medical Equipment Co., Ltd.
- Publication Date: 2020-12-31
- Product Name: electric wheelchair
- Recall Level: Level 3
- Recall Reason: The product was deemed unqualified by the inspection unit in the 2020 National Medical Device Supervision and Spot Check. The unqualified items included external markings, suppression of driving during charging, maximum speed, and braking on level roads.
- Discovering Company: Wen'an County Wantong Medical Equipment Co., Ltd.
- Manufacturing Company: Wen"an County Wantong Medical Equipment Co., Ltd.
- Summary: Wen'an County Wantong Medical Device Co., Ltd. initiated a Level III voluntary recall of 63 units of its WT-100W electric wheelchairs following inspections conducted as part of the 2020 National Medical Device Supervision and Inspection. The regulatory framework for this action falls under the National Medical Products Administration (NMPA) and the Hebei Provincial Drug Administration.

Inspection reports, received on September 2, 2020, identified several critical non-conformities across multiple product batches (20190605, 20191110, 20200424, 20200610, 20200518). Key violations included issues with external markings, specifically the omission of production date and batch information. Additionally, batch 20190605 exhibited defects related to inhibition of movement during charging, maximum speed, and braking performance on level surfaces. Batch 20200424 also showed non-compliance concerning inhibition of driving while charging.

Upon receiving these findings, the company promptly investigated the root causes, implemented corrective actions, and reinforced production process controls. Required actions involved notifying customers and distributors on September 3, 2020, to cease sales and usage of the affected products and arrange for their return. By September 18, 2020, the recalled products had been successfully returned to Wen'an County Wantong Medical Device Co., Ltd.

Company: https://www.globalkeysolutions.net/companies/wenan-county-wantong-medical-equipment-co-ltd/89b106d0-48ee-48ea-9ebd-5480d0adb747/