CLASS II Device recall · Reported 11 Sep 2019 · FDA Enforcement Report

HS Hi-R NEO 900A Reference # recalled by Haag-Streit USA

Haag-Streit USA is recalling HS Hi-R NEO 900A Reference # 657 821. The recall was initiated on 31 Jul 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesThe Error only occurs in combination with the following floor stands FS 2-21, FS 2-25, FS 3-45 with the software REF 615 586 in the versions 10.1.xx to 11.3.xx 1. Product: FS 2-21, Reference # 615 510 Serial # 101 to 360, SW-Version: 10.1.xx to 11.3.xx 2. Product: FS 2-21, Reference # 615 510, serial # from 361 3. Product: FS 2-25, Reference # 615 550, Serial # 101 to 376, SW Version: 10.1.xx to 11.3.xx 4. Product: FS 2-25, Reference # 615 550, Serial # from 377 4. Product: FS 3-45, Reference # 615 705, Serial #from 101

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2483-2019
FDA event ID: 83571
Recalling firm: Haag-Streit USA, Mason, OH
Classification: Class II
Status: Terminated
Recall initiated: 31 Jul 2019
FDA classified: 5 Sep 2019
Reported: 11 Sep 2019
Type: Voluntary: Firm initiated
Customers notified by: Visit
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

31 Jul 2019	Recall initiated by company
5 Sep 2019	Classified by FDA	+36 days
11 Sep 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

software error in the central control unit of the floor stand.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/HS Hi-R NEO 900A NIR and HS ALLEGRA 900/590/90 are designed for use in Ophthalmology and in other disciplines where a vertical line of viewing is required. Due to their high maneuverability, the HS ALLEGRA range of operating microscopes are qualified for further applications, in particular ENT- and reconstructive microsurgery are possible, because their line of sight can be tilted or adjusted horizontally. The HS ALLEGRA 590 is particular because of its multidisciplinary application possibilities.

Where it was distributed

US in the state of OH

Questions about this recall

Why was it recalled?

software error in the central control unit of the floor stand.

Which lots are affected?

The Error only occurs in combination with the following floor stands FS 2-21, FS 2-25, FS 3-45 with the software REF 615 586 in the versions 10.1.xx to 11.3.xx 1. Product: FS 2-21, Reference # 615 510 Serial # 101 to 360, SW-Version: 10.1.xx to 11.3.xx 2. Product: FS 2-21, Reference # 615 510, serial # from 361 3. Product: FS 2-25, Reference # 615 550, Serial # 101 to 376, SW Version: 10.1.xx to 11.3.xx 4. Product: FS 2-25, Reference # 615 550, Serial # from 377 4. Product: FS 3-45, Reference # 615 705, Serial #from 101

Where was it sold?

US in the state of OH

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 83571

This product is part of a recall event; the main page for the event is HS Hi-R NEO 900A NIR Reference # recalled by Haag-Streit USA.

Reported	Class	Recall	Company	Reason	Where
11 Sep 2019	CLASS II	HS Hi-R NEO 900A NIR Reference # recalled by Haag-Streit USA	Haag-Streit USA	Device Malfunction	OH
11 Sep 2019	CLASS II	HS Hi-R NEO 900 Reference # recalled by Haag-Streit USA	Haag-Streit USA	Device Malfunction	OH

More recalls from Haag-Streit USA

All 9

Reported	Class	Recall	Company	Reason	Where
19 Jan 2022Device	CLASS II	OCT-Camera 211 01 A1, Running recalled by Haag-Streit USA	Haag-Streit USA	Device Malfunction	Nationwide
19 Jan 2022Device	CLASS II	OCT-Camera 211 01 A3 recalled by Haag-Streit USA	Haag-Streit USA	Device Malfunction	Nationwide
19 May 2021Device	CLASS II	Eyesuite 9.3.1 software, Lenstar, Model LS900: ac-powered slit-lamp recalled	Haag-Streit USA	Device Malfunction	Nationwide
30 Dec 2020Device	CLASS II	Haag Streit Surgical Floor stands FS 2-11 recalled	Haag-Streit USA	Device Malfunction	Nationwide
11 Sep 2019Device	CLASS II	HS Hi-R NEO 900 Reference # recalled by Haag-Streit USA	Haag-Streit USA	Device Malfunction	OH

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