FDADecember 8, 2017device
Widefield OCT software feature for the Spectralis HRA+OCT and variants
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
FDA notified Heidelberg Engineering that a 510(k) clearance is needed for the SPECTRALIS Widefield OCT feature, and, on November 27, 2017, Heidelberg Engineering submitted a new 510(k) for this feature. FDA has asked Heidelberg Engineering to instruct customers not to use the Widefield OCT software feature on the SPECTRALIS device until 510(k) clearance has been obtained for this software feature.
What to do
FDA enforcement status: Terminated
Brands named
heidelberg engineeringheidelberg
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCNewCosplay Children's Sleepwear Recalled Due to Violation of Federal Flammability Standards and Burn Hazard; Imported by Shanghai Jing Cheng Landscape Engineering Company; Sold Exclusively at Amazon.com2023-01-19
- FDASPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.2019-07-03
- FDADraco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Product Number HY0305Z2019-05-08
- FDAFirst Step Draco Pad, Product Number EP-4D2019-05-08
- FDADraco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z Product Usage: Multi-tiered enzymatic detergent contains lipase, carbohydrase, amylase and protease. It effectively dissolves blood, fat, tissue, protein and most other forms of organic material Ready to use. Non-toxic, latex-free and neu...2018-12-14
- FDANeuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.2018-09-04
- FDADraco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic Detergent, Catologue Number HY0305Z2018-03-21
- FDAFirst Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-42018-03-21
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →