Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, S2000, S1610 multimod…
Heidelberg Engineering GmbH · Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a re…
Open FDA's page for this record- Cfres ID
- 221928
- Product res number
- Z-3215-2026
- Event date initiated
- 2026-08-06
- Event date posted
- 2026-09-18
- Recall status
- Open, Classified
- Res event number
- 99595
- Product code
- OBO
- Firm FEI number
- 3002807157
- Recalling firm
- Heidelberg Engineering GmbH
- Address 1
- Max-Jarecki-Str. 8 8 max-jarecki-str.
- City
- Heidelberg
- Country
- Germany
- Root cause description
- Component design/selection
- Product quantity
- 87
- Product description
Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, S2000, S1610 multimodal imaging platform optimized for the posterior segment of the eye
- Code info
UDI-DI 04059237000235 Lot Code: Spec-07265, Spec-11121, Spec-11281, Spec-12096, Spec-13305, Spec-14403, Spec-15282, Spec-15587, Spec-20071, Spec-20348, Spec-20351, Spec-20591, Spec-20605, Spec-23473, Spec-23941, Spec-23950, Spec-23975, Spec-24507, Spec-24558, Spec-24582, Spec-24611
- Reason for recall
Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a result. Falling stand may cause impact or crushing injuries, particularly to the feet, legs, hands or arms of the operator or nearby persons.
- Action
Firm began notifying US customers on August 6, 2026 via email. Instruction to Customers: There is a possibility that the castor wheels of the Flex stand are not properly attached. The wheels may come loose when the Flex Module is being pulled or pushed during movement or transportation, affecting the stability of the stand. As a result, the Flex stand may tip over if not correctly handled or supported by the operator. Users shall schedule a service appointment with your Heidelberg Engineering service partner as soon as possible so that the castor fastenings can be inspected and, if necessary, corrected.
- Distribution pattern
Worldwide - US Nationwide distribution in the state of Massachusetts and the countries of Australia, Costa Rica, Germany, France, India, Israel, Italy, Canada, Mexico, Netherlands, Austria, Philippines, Poland, Saudi Arabia, Switzerland, Spain. South Africa. Thailand, Czech Republic, United Kingdom, Vietnam.
- K numbers
- K181594
- Harmonized identifiers (openFDA)
- Device name
- Tomography, Optical Coherence
- Medical specialty description
- Ophthalmic
- Regulation number
- 886.1570
- Device class
- 2
- K number
- K233561, K250553, K083291, K163195, K222200, K170164, K252633, K141844, K071250, K250868, K231673, K230897, K071839, K112184, K101223, K181534, K173707, K083316, K092470, K163475, K182942, K241081, K190732, K161194, K213265, K180660, K072971, K201252, K233421, K062552, K152205, K223557, K113129, K111157, K162783, K233933, K173119, K211817, K233602, K150977 +27 more
- Registration number
- 9614730, 9616199, 3004441848, 9615030, 3020723591, 2918630, 3010000450, 3008348697, 1054713, 3002807715, 9614661, 3033566, 3013403214, 9615010, 8020986, 2936921, 3038614464, 2242863, 8043762, 3005744933, 9617167, 3008729548, 8030392, 3038356864, 1000204638, 9611269, 3004026651, 3005950902, 3003589956, 3009746052, 1000181430
- FEI number
- 3004441848, 3001362763, 3003768492, 4196, 3020723591, 2918630, 3010000450, 3008348697, 3002807782, 3003060634, 3002807715, 3013403214, 3002680900, 1000114111, 3003481798, 1000582291, 2936921, 3038614464, 2242863, 3005744933, 3002807157, 3008729548, 3038356864, 1000204638, 3002785343, 3005950902, 3003589956, 3009746052, 1000175127, 1000181430