| Date Initiated by Firm | November 03, 2021 |
|---|
| Create Date | January 10, 2022 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0477-2022 |
|---|
| Recall Event ID |
89176 |
| 510(K)Number | K142953 |
|---|
| Product Classification |
Ophthalmoscope, ac-powered - Product Code HLI
|
| Product | OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4 |
|---|
| Code Information |
Serial no. 0005, 0023 |
| FEI Number |
1000136533
|
Recalling Firm/
Manufacturer |
Haag-Streit USA Inc
3535 Kings Mills Rd
Mason
OH
45040-2303
|
| For Additional Information Contact | Mike Dietz
513-486-1513 |
|---|
Manufacturer Reason
for Recall | Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off |
|---|
FDA Determined
Cause 2 | Software design (manufacturing process) |
|---|
| Action | Haag-Streit USA send out field safety notice 2021-10/01 on November 03, 2021.
Actions to be taken by the customer/user:
Should one or more continuous straight lines be displayed on the screen of the OCT camera during an operation on the posterior segment of the patient's eye (see picture in the notification), the described risk possibly exists.
1. Switch off the OCT camera immediately (menu OCT -> Switch off).
2. The OCT camera is not permitted to be used any more. Please contact your
responsible country representative.
3. Perform the software update of the OCT camera. You will receive the new software
version via your local representative, who will correct the error.
4. Please fill out and return the enclosed response form as soon as the software
update has been performed
5. Please ensure that all users of the products mentioned are aware of and receive this urgent safety information. If you have passed the products to third parties, please forward a copy of this information and inform the contact person listed in the notification.
6. Software update organization will be performed by Haag-Streit USA, Inc. Please contact Mike Dietz at (513) 486-1513 or via email: fieldsafetynotice@haag-streit-usa.com for questions concerning this procedure.
|
|---|
| Quantity in Commerce | 2 devices quarantined in US |
|---|
| Distribution | US Nationwide distribution in the states of OH, IN. |
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = HLI
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