Z-1510-2014Class II

Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical...

Name: Z-1510-2014 Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2014-03-10
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-03-10 / Terminated / root cause: design

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143. Used to produce images... on 2014-03-10. FDA classified it as Class II and gives the reason as "Slippage of the radius drive belt in the relative 180 degree orientation of the superior positioned detector head will allow the detector head to drift down and potentially come in direct contact with the patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1510-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-10
Posted: 2014-04-26
Terminated: 2015-08-04
Recalling firm: Philips North America LLC
Product: Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143. Used to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: Slippage of the radius drive belt in the relative 180 degree orientation of the superior positioned detector head will allow the detector head to drift down and potentially come in direct contact with the patient.
Root cause tag: design
FDA root cause: Device Design
Action: On 03/10/2014, the firm sent Urgent - Medical Device Correction letters to their customers. The letter identified the affected product, the reason for recall, the hazard involved, and the actions that should be taken by customers. Customers are to cease use of the identified procedures until implementation of the Field Change Order. Additionally, customers should sign and return the attached Customer Response Form within 10 days of receipt, acknowledging that they have read and understood the Field Safety Notice and Addendum. The Field Safety Notice must be placed in customers' User Documentation. Customers are to contact their local Philips Healthcare representative or office, if they need further information or support.
Quantity in commerce: 1,043 cameras
Distribution: Worldwide Distribution -- USA, and the countries of Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, Ireland, Italy, Korea, Lebanon, Malaysia, Netherlands, Norway, Pakistan, Portugal, Russia, Singapore, Spain, Sweden, Thailand, & United Kingdom.
Product codes and lots: ADAC Vertex Plus & ADAC Solus System Code: 88297, Serial #'s: 11, 1006, 1008, 1027, 1092, 1097, 2035, 2038, 2047, 3059, 3060, 3064, 4007, 4078, 6052, 6261, 8002, 10252, 10630, 11090, 85247, 513519, 513520, 940384, 9205345, 9408136, 9503084, 9506016, 9511123, 9512009, 9512018, 9601012, 9601015, 9601016, 9601024, 9601036, 9602161, 9602254, 9603336, 9604016, 9604021, 9605024, 9605026, 9605037, 9606211, 9607015, 9607024, 9608031, 9608046, 9608049, 9608052, 9609063, 9609081, 9610058, 9611035, 9611077, 9611082, 9612072, 9702095, 9702150, 9703154, 9703165, 9704044, 9704178, 9704183, 9705004, 9705186, 9706005, 9706182, 9706189, 9707002, 9707047, 9707050, 9707054, 9708062, 9708065, 9708076, 9708078, 9708084, 9708088, 9708227, 9709022, 9709061, 9710121, 9710127, 9710244, 9711025, 9711034, 9711036, 9711074, 9711271, 9711291, 9801047, 9801227, 9801232, 9801297, 9802050, 9802255, 9802260, 9802300, 9802306, 9802397, 9803003, 9803014, 9803067, 9803083, 9803269, 9803272, 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M@6924VM, M@6931VM, M@6932VM, M@6943VM, M@6946VM, M@6947J, M@6985J, M@7003VA, M@7004VA, M@7005VA, M@7017VM, M@7024VM, M@7034K, M@7042VM, M@7053VM, M@7070VM, M@7073VM, M@7085K, M@7086J, M@7095VM, M@7096VM, M@7099K, M@7100VM, M@7101VM, M@7102VM, M@7108VM, M@7109VM, M@7151VM, M@7166K, M@7171VM, M@7172K, M@7181J, M@7190VM, M@7198VA, M@7205K, M@7215K, M@7216VM, M@7217VM, M@7221VA, M@7222VA, M@7229VM, M@7233VM, M@7237VM, M@7245J, M@7246VM, M@7247VM, M@7250VM, M@7253K, M@7300J, M@7308VM, M@7358VA, M@7376VM, M@7380VM, M@7384VM, M@7390VM, M@7393VM, M@7394VM, M@7410VM, M@7420VM, M@7463VM, M@7464VA, M@7470VM, M@7490VM, M@7494K, M@7501VM, M@7503VM-FU1, M@7504VM, M@7505VM1, M@7514VM, M@7515VM, M@7536VM, M@7537VM, M@7538VM, M@7556VM, M@7557VM, M@7569VM, M@7572VM, M@7591VM, M@7592VM, M@7603K, M@7605VM, M@7606VM, M@7623K, M@7624K, M@7626K, M@7627K, M@7628VA, M@7638VM, M@7643VM, M@7654VM, M@7664VM, M@7665K, M@7673VM, M@7674K, M@7679VM, M@7682K, M@7685VM, M@7691VM, M@7695VM, M@7697VM, M@7723VM, 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M@8903K, M@8906RK, M@8920VM, M@8922VM, M@8935K, M@8936K, M@8942K, M@8943K, M@8948RV, M@8955K, M@8966K, M@8967K, M@8990K, M@8996VM, M@900K, M@9032K, M@9041K, M@9046K, M@9049VM, M@9063K, M@9080K, M@9081K, M@9085K, M@9091VM, M@9107RV, M@9118K, M@9129K, M@9131K, M@9140K, M@9166VM, M@9185K, M@9186K, M@9191K, M@9194VM, M@9221VM, M@9222VM, M@9231K, M@9247RV, M@9252VM, M@9267VM, M@9283K, M@9293VM, M@9308K, M@9309RV, M@9316VM, M@9327K, M@9337K, M@9338VM, M@9340VM, M@9344K, M@9349K, M@9360VM, M@9418VM, M@9426K, M@9434K, M@9442K, M@9452K, M@9471RV, M@9476K, M@9479K, M@9479K, M@9480K, M@9502K, M@9515VM, M@9522K, M@9525K, M@9532VM, M@9542VM, M@9543K, M@9562K, M@9563K, M@9566K, M@9583VM, M@9590K, M@9594K, M@9598K, M@9607VM, M@9609K, M@9622K, M@9639K, M@9646K, M@9653VM, M@9672VM, M@9712K, M@9724VM, M@9730K, M@9765K, M@9769K, M@9799K, M@9816K, M@9831VM, M@9834K, M@9837K, M@AMT1258, M@MCD6416VM, M@MCD7036VM, M@O1317, M@R372820, M@S5195VA, M@S5365-V, M@S5820VM, M@S5907V11, M@S6155VA, M@S7115VM, M@S7156VM, M@S7223K, M@S7559VA, M@S7571VM, M@S7817K, M@S7856K, M@S7864K, M@S7904VM, M@S7941VA, M@S8687K, N@9369VM, R03010363, S0011003, S6235VM, UNK-6597VM, UNK-7590VM, UNK-8097J1, UNK-8533VM1, UNK-8860VM, UNK-9868K, V0007070, V0012099, V0104109, V0104110, V0105112, V0106121, V0106123, V0106124, V01070133, V01090146, V01100151, V01100156, V02050166, V02070174, V02070179, V02080190, V02080194, V02080196, V02080200, V03060224, & V03070229. ADAC Vertex V60 System Code: 882030; Serial #'s: 10588, 9601004, V0005062, V03080235, V03080236, & V2070177. ADAC Vertex Classic System Code: 890122; Serial #'s: 64, 103, 500, 3334, 5005, 9308007, 9309020, 9310032, 9401059, 9401061, 9403076, 9404106, 9407122, 9410002, 9411006, 9411016, 9501210, 9502067, 9502070, 9503003, 9503079, 9503109, 9504019, 9504099, 9505021, 9505124, 9506140, 9506178, 9508171, 9508184, 9508193, 9509206, 9510222, 9510226, 9601146, 9602249, 9608042, 9609084, 9901004, 9901135, 0407V, 0682V, 0795V, 0822VP2, 20, 5405V, 93-10660-1292, 9408128, 9411007, 9502086, 9508169, 9509198, 9509199, B0106154, B02120033, M@10229AMT, M@207JD, M@4324V, M@4404V, M@4431V, M@4432V, M@4480V, M@4623V, M@4630V, M@4639V, M@4686V, M@4692V, M@4835V, M@4858V, M@4893V, M@4959V, M@5032V, M@5033V, M@5038V, M@5105V, M@5145V, M@5158V, M@5189V, M@5280V, M@5289V, M@5338V, M@5360V, M@5398V, M@5407V, M@5412V, M@5431V, M@5439V, M@5467V, M@5474V, M@5476V, M@5497V, M@5498V, M@5515V, M@5526V, M@5590V, M@5617V, M@5627V, M@5661V, M@5662V, M@5663V, M@5664V, M@5665V, M@5681V, M@5688V, M@5689V, M@5751V, M@5752V, M@5782V, M@5811V, M@5835V, M@5869V, M@5900V, M@5913V, M@5915V, M@5960V, M@5970V, M@6004V, M@6007V, M@6010V, M@6056V, M@6900V, M@9304RV, M@9374RV, M@9645RV, M@MVS5236V, M@MVS5852V, M@O1325 & UNK-AMT1238A.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1510-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1510-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-07	2014-04-25

Product code KPS

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)