Z-1493-2018Class II

Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers

Name: Z-1493-2018 Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers
Creator: Beijing Syntech Laser Co., Ltd
Published: 2017-07-03
License: https://open.fda.gov/license/

Beijing Syntech Laser Co., Ltd / initiated 2017-07-03 / Open, Classified / root cause: manufacturing process

FDA source

Beijing Syntech Laser Co., Ltd began a recall of Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers on 2017-07-03. FDA classified it as Class II and gives the reason as "The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007"". 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-1493-2018
Classification: Class II
Status: Open, Classified
Initiated: 2017-07-03
Posted: 2018-05-02
Recalling firm: Beijing Syntech Laser Co., Ltd
Product: Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Beijing Syntech Laser measures to be taken: 1. Beijing Syntech Laser Co. Ltd. has sent notifications to all relevant dealers, distributors, and purchasers, 2. Beijing Syntech Laser Co. Ltd. will send certification labels and instructions to apply the label to the product to all relevant dealers, distributors, and purchasers, 3. The corrections will be conducted at no cost to the purchaser, and 4.The corrective action will be completed by August 1st, 2018. CDRH approves the CAP subject to the following condition: Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22, if it hasnt been already. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. For further questions please call (360) 325-7028
Quantity in commerce: 6
Distribution: US Distribution
Product codes and lots: Model APOLLO 1V+Medical Platform

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1493-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1488-2018	Class II	Ongoing	FDA Mandated	2018-05-09	2018-05-02
Z-1489-2018	Class II	Ongoing	FDA Mandated	2018-05-09	2018-05-02
Z-1490-2018	Class II	Ongoing	FDA Mandated	2018-05-09	2018-05-02
Z-1491-2018	Class II	Ongoing	FDA Mandated	2018-05-09	2018-05-02
Z-1492-2018	Class II	Ongoing	FDA Mandated	2018-05-09	2018-05-02
Z-1493-2018	Class II	Ongoing	FDA Mandated	2018-05-09	2018-05-02
Z-1494-2018	Class II	Ongoing	FDA Mandated	2018-05-09	2018-05-02
Z-1495-2018	Class II	Ongoing	FDA Mandated	2018-05-09	2018-05-02

Product code GEX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)