# China NMPA Product Recall - Cirrus HD-OCT Optical Coherence Side Scanner

Source: https://www.globalkeysolutions.net/records/china_product_recall/carl-zeiss-meditec-inc/32862e66-aa36-4e07-940b-20d42eba1e70/
Source feed: China

> China NMPA product recall for Cirrus HD-OCT Optical Coherence Side Scanner by Carl Zeiss Meditec, Inc published May 16, 2011. Recall level: . Carl Zeiss Meditec, Inc., in cooperation with its Chinese subsidiary Zeiss Optical Instruments (Shan

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Carl Zeiss Meditec, Inc. is recalling its optical coherence side-mounted scanner.
- Company Name: Carl Zeiss Meditec, Inc
- Publication Date: 2011-05-16
- Product Name: Cirrus HD-OCT Optical Coherence Side Scanner
- Recall Reason: There is a defect in the instrument and reading software of CTUS™ HD-OCT versions 5.0.0 and 5.1.0. In the following workflow, after the operator (1) acquires data, (2) logs out without analysis, and (3) logs back in and acquires data from another patient, the examination data of the second patient may be incorrectly saved under the name of the first patient.
- Discovering Company: Zeiss Optical Instruments (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Carl Zeiss Meditec, Inc
- Summary: Carl Zeiss Meditec, Inc., in cooperation with its Chinese subsidiary Zeiss Optical Instruments (Shanghai) International Trading Co., Ltd., initiated a voluntary recall of its Cirrus HD-OCT Optical Coherence Side Scanners. The recall, reported on March 31, 2011, and published by the National Medical Products Administration (NMPA) on May 16, 2011, addresses a significant software defect.
The core issue involves instrument and reading software versions 5.0.0 and 5.1.0. A critical defect was identified where, if an operator acquires data, logs out without analysis, then logs back in to acquire data for a different patient, the second patient's examination data might be erroneously saved under the first patient's name. This data integrity flaw affects 140 units sold in China and has global implications, involving numerous countries.
Under the NMPA's regulatory oversight, the company's required corrective actions include identifying and notifying all affected customers, providing immediate guidelines for accurate image saving with existing software, and subsequently distributing and installing the corrected software version 5.1.1 via dispatched engineers for individual customer upgrades. This proactive measure aims to resolve the data misattribution issue and ensure patient record accuracy.

Company: https://www.globalkeysolutions.net/companies/carl-zeiss-meditec-inc/4b4b2c54-38a4-4ff6-9ab8-40db8b4c2f6d/