Westborough, MA, United States
GE Healthcare Biosciences recalls
1 recall recorded since 2018, most recently on 10 September 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 10 September 2018
- Terminated
- 12 May 2020
- Reason
- Non-conformance with the DeltaVision OMX SR, the interlocks are not wired in a redundant fashion to make the interlock system single-fault tolerant.
- Distribution
- Worldwide - US Nationwide Distribution
- Initiated
- FDA Mandated
- Recall number
- Z-0388-2019
- DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging System is a piece of laboratory equipment for super resolution imaging offluorescently-la beling biological samples. Techniques
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.