Z-2621-2024Class II

Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to...

Name: Z-2621-2024 Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to...
Creator: DKK Dai-Ichi Shomei Co., Ltd.
Published: 2024-07-09
License: https://open.fda.gov/license/

DKK Dai-Ichi Shomei Co., Ltd. / initiated 2024-07-09 / Open, Classified / root cause: manufacturing process

FDA source

DKK Dai-Ichi Shomei Co., Ltd. began a recall of Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility... on 2024-07-09. FDA classified it as Class II and gives the reason as "The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2621-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-09
Posted: 2024-08-14
Recalling firm: DKK Dai-Ichi Shomei Co., Ltd.
Product: Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
Product code: FSY Light, Surgical, Ceiling Mounted
Reason for recall: The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On July 9, 2024 URGENT: Aurora 7 Lighthead Series RECALL letters were sent to customers. Actions to be taken by the customer: Contact the end users and tell them to discontinue the use of the product. Please send an acknowledgement letter or email to Dai-ichi Shomei to let us know that you have received this Field Action Advisory Notice within 3 days after you receive the Notice. Actions to be Taken by the Manufacturer: The physical correction will be announced later. Contact information for questions: email [email protected]
Quantity in commerce: 538 units
Distribution: Domestic: Nationwide Distribution International: Australia, Canada, Egypt, Hong Kong, Indonesia, Japan, Jordan, Netherlands, New Zealand, Philippines, Singapore, South America, South Korea, Thailand, UAE.
Product codes and lots: Model Number: AUA7-LH/7TV-LH; UDI-DI: 10841736100025; Serial Numbers: 07120133, 2015-03-0001, 2015-03-0002, 2015-03-0003, 2015-03-0004, 2015-03-0005, 2015-03-0006, 2015-03-0007, 2015-03-0008, 2015-03-0009, 2015-03-0010, 2015-04-0011, 2015-04-0012, 2015-04-0013, 2015-04-0014, 2015-04-0015, 2015-04-0016, 2015-04-0017, 2015-04-0018, 2015-04-0019, 2015-04-0020, 2015-04-0021, 2015-04-0022, 2015-04-0023, 2015-04-0024, 2015-04-0025, 2015-05-0026, 2015-05-0027, 2015-05-0028, 2015-05-0029, 2015-05-0030, 2015-05-0031, 2015-05-0032, 2015-05-0033, 2015-05-0034, 2015-05-0035, 2015-05-0036, 2015-05-0037, 2015-05-0038, 2015-05-0039, 2015-05-0040, 2015-06-0041, 2015-06-0042, 2015-06-0043, 2015-06-0044, 2015-06-0045, 2015-06-0046, 2015-06-0047, 2015-06-0048, 2015-06-0049, 2015-06-0050, 2015-06-0051, 2015-06-0052, 2015-06-0053, 2015-06-0054, 2015-06-0055, 2015-07-0056, 2015-07-0057, 2015-07-0058, 2015-07-0059, 2015-07-0060, 2015-07-0061, 2015-07-0062, 2015-07-0063, 2015-07-0064, 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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2621-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2618-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-21	2024-08-14
Z-2619-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-21	2024-08-14
Z-2620-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-21	2024-08-14
Z-2621-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-21	2024-08-14

Product code FSY

K071698Class IIAurora LED Series Surgical LightsSkytron, Div. the Kmw Group, Inc. / cleared 2007-07-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)