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

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.