| | Class 2 Device Recall LED Surgical Light |  |
| Date Initiated by Firm | February 28, 2017 |
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| Date Posted | March 10, 2017 |
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| Recall Status1 |
Terminated 3 on January 08, 2018 |
| Recall Number | Z-1699-2017 |
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| Recall Event ID |
76633 |
| 510(K)Number | K060802 |
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| Product Classification |
Light, surgical, ceiling mounted - Product Code FSY
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| Product | The Stryker Visum LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light. Affected part numbers are 0682001432 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/FP), 0682001286 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P/FP), 0682001298 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P), 0682001299 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P/5P), 0682001300 (EDS LIGHT SUSPENSION, CENTRAL AXIS, FP/5P/5P), 0682001433 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P), 0682001434 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/5P), 0682001435 (EDS LIGHT SUSPENSION, CENTRAL AXIS, FP/9P/5P)
Product Usage:
The Stryker Visum LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light |
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| Code Information |
"Serial Numbers: 100000000098399 100000000099187 100000000099193 100000000093937 100000000094391 100000000093936 100000000087555 100000000091032 100000000093938 100000000093928 100000000093939 100000000098397 100000000092672 100000000093927 100000000106675 100000000106685 100000000109560 100000000109569 100000000109570 100000000086360 100000000089194 100000000091766 100000000091778 100000000098401 100000000099325 100000000103228 100000000090520 100000000102434 100000000102439 100000000103111 100000000088303 100000000089467 100000000094993 100000000095927 100000000101580 100000000092699 100000000101590 100000000101591 100000000103686 100000000109291 100000000097048 100000000112633 100000000087549 100000000094982 100000000091762 100000000112607 100000000112609 100000000091531 100000000106681 100000000106682 100000000106684 100000000106159 100000000091728 100000000103271 100000000090522 100000000099356 100000000089970 100000000090530 |
Recalling Firm/
Manufacturer |
Stryker Communications
1410 Lakeside Pkwy Ste 100
Flower Mound TX 75028-4026
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| For Additional Information Contact | Julie Baker
972-834-8656 |
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Manufacturer Reason
for Recall | The potential hazard that can arise for the combination of the missing screws and the overloading by the end user is insufficient mount force that causes the equipment to fall. |
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FDA Determined
Cause 2 | Device Design |
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| Action | Stryker sent an Urgent Medical Device Correction letter dated March 3, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. Distributors will notify customers via tracked Customer Notification Letter. A method of written communication will include a confirmation of delivery. For questions contact Stryker Technical Support at 800-243-5135 or comm.techservices@stryker.com |
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| Quantity in Commerce | 292 devices (in US) |
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| Distribution | Worldwide distribution - United States Nationwide - Australia, Canada, Great Britain, Japan, Netherlands and Puerto Rico |
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| Total Product Life Cycle | TPLC Device Report |
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = FSY
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