Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2017-07-14 | Z-0847-2018 | Class II | Terminated | A software issue may result in the previous settings being applied instead of the default settings or the unit may skip the startup leak test.Distribution: Worldwide Distribution - US Nationwide | 2875 in total | clearance family |
| 2016-08-04 | Z-2692-2016 | Class II | Terminated | Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System to reduce the potential for flammable liquids coming into contact with electrical components in the Stainer module possibly causing a fire.Distribution: Worldwide Distribution to US (nationwide) and Internationally to Australia, Belgium, Canada, China, Croatia, Czech Republic, France, Germany, Hong Kong, India, Israel, Italy, Japan, Kuwait, Malaysia, Mayotte, Mexico, New Zealand, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Slovakia, South Korea, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, and Vietnam. | 759 units total (358 units in US) | clearance family |
| 2016-06-15 | Z-2689-2016 | Class II | Terminated | Potential for a leak to occur on the back-up O2 and air e-size cylinder yokes on the A7 Anesthesia Delivery System.Distribution: US Nationwide Distribution to AL, MA, MD, MN, MO, NE, NJ, OK, OR, PA and VA; and Canada | 167 units (165 units - US) and (2 units - International) | clearance family |
Regulatory clearances
- 510(k)K151954Substantially equivalent (SESE) · 2015-10-27clearance family
Predicate lineage
- K151954
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2017-04-14 | NAI | No action indicated | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 0 |
| 2017-04-14 | VAI | Voluntary action indicated | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | 0 |
| 2017-04-14 | VAI | Voluntary action indicated | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | 0 |
| 2017-04-14 | NAI | No action indicated | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 0 |
| 2015-05-15 | VAI | Voluntary action indicated | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 1 |
| 2012-04-12 | VAI | Voluntary action indicated | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 5 |
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