# China NMPA Product Recall - Ventilator

Source: https://www.globalkeysolutions.net/records/china_product_recall/datex-ohmeda-inc/3c8ef712-0724-4d89-adab-78f0071bbaf9/
Source feed: China

> China NMPA product recall for Ventilator by Datex-Ohmeda, Inc. published February 15, 2015. Recall level: Level II. GE Healthcare Systems Trading Development (Shanghai) Co., Ltd., acting on behalf of manufacturer Dat

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. initiates voluntary recall of ventilators
- Company Name: Datex-Ohmeda, Inc.
- Publication Date: 2015-02-15
- Product Name: Ventilator
- Recall Level: Level II
- Recall Reason: GE Healthcare recently noted that certain Engstrom ventilators have a higher likelihood of having their casters and base damaged, which could cause the ventilator to fall or tilt (lose balance). Such falls/tilts could result in serious injury to patients or clinicians.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: Datex-Ohmeda, Inc.
- Summary: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd., acting on behalf of manufacturer Datex-Ohmeda, Inc., initiated a voluntary Class II medical device recall for specific Engstrom Carestation ventilators. This recall was reported to the National Medical Products Administration (NMPA) on January 29, 2015, and publicly announced on February 15, 2015. The recall affects 81 units sold in China, with similar issues noted in other international regions. The core issue centers on an increased likelihood of damage to the casters and base components of the affected ventilators. This defect creates a significant safety hazard, as compromised casters could cause the ventilator to become unstable, fall, or tilt, potentially leading to serious injury for patients or clinical staff. To address this, GE Healthcare is implementing two key corrective actions: first, informing customers via a letter detailing the issue and providing guidance for self-checking; and second, deploying engineers to customer sites to perform necessary on-site repairs and corrections to the affected products, thereby restoring their stability and safety.

Company: https://www.globalkeysolutions.net/companies/datex-ohmeda-inc/3f7d50b4-53f8-4a07-a7a6-7a3c0147c9e2/