Egyptian Drug Authority · Egypt
DEA-EG-2021-0011
Tier 1 · Regulator-publishedUnclassifiedRecallStatus · active
- Issuing authority
- Egyptian Drug Authority (EDA)
- Authority reference
- Periodic report no.(11) For 2021
- Date issued
- 01 Mar 2021
- Recorded by us
- 2026-09-06 19:49:24 UTC
- Product
- Engstrom Ventilators
- INN / active substance
- Not stated by the issuing authority
- Dosage form
- Not stated by the issuing authority
- Strength
- Not stated by the issuing authority
- Manufacturer
- Not stated by the issuing authority
- Manufacturer country
- Not stated by the issuing authority
- MAH or importer
- Not stated by the issuing authority
- Batch numbers
- Not published with the notice
- Expiry dates
- Not published with the notice
- Action type
- Recall
- Classification
- Not stated by the issuing authority
- Indicative severity
- Not assessed by Drug Eye Africa
- Defect category
- Not stated by the issuing authority
- Product type
- Not stated by the issuing authority
- ATC code
- Not stated by the issuing authority
- Affected markets
- Egypt — no market beyond the issuing country was named on the notice
- Cross-border event
- Not linked to a cross-border event
- Notice text
- ARRAS REPUBLIC OF EGYPT جمصوريه مصر بعرييه م EGYPTIAN DRUG AUTHORITY Jnl المصرية clgalld im CA OF OPERATIONS 2 4 ] 7 plas "م د ب لمركزية 4) €DM إدارة التفتيش على المستلزمات الطبية ا MEDICAL DEVICE INSPECTION 0 7 ora 7 2021 20.5 (\\) متشو دور ى رقم السيد الدكتور / وكيل الوزاره للشئون الصحيه بمحافظة................. ” ادارة الصيدلة " برجاء ضبط وتحريز ما يوجد بالسوق المصري بعد اتخاذ كافة الاجراءات المخزنية و ذلك للأرقام : المسلسلة الواردة من المستلزم الطبي الآتي بياناته 01501100165, CBCN00729, CBCN00738, CBCN00776, | 1505-9000-000 CBCN00777, CBCN01328,CBCN01329, CBCN01696, CBCN01702, CBCN01725, CBCN01726, CBCN01756, CBCP01229,CBCP02256, CBCP02268, BCP02275 ,CBCP02277, CBCP02282, CBCP02283, CBCP02285 Engstrom Ventilators CBCQ01400, CBCQ01402, CBCQ01409, 1505-9003-000 CBCQ01416, 0150001421, CBCQ01436, CBCQ01440, CBCQ01441, CBCQ01464, CBCQ01466, 0150001491, CBCP00114, CBCP00132. .GE Healthcare الشركة المنتجة: الشركة باجراء تبديل بسبب الآتي: ALS على ما تم افادتنا به من الإدارة المركزية للرعاية الصيدلية من gli Certain Engstrom ventilators at your hospital were serviced and modified with parts and software from another model (CARESCAPE R860) that were not fully tested or approved for use on Engstrom.. Based on the service and installation testing completed on these modified Engstrom devices, basic performance has been demonstrated. While there have not been any reported failures or safety issues to date, if a potential issue did arise from these modifications, the failure could theoretically lead to inappropriate ventilation and/or insufficient oxygen to the patient. مع تسليم متدوب الشركة الأحراز بعد أخن التعهد اللازم بعدم فض الأختام إلا فى وجود مفتشى هيثئة الدواء تفضلوا بقبول فائق الاحترام؛؛ gu رئيس القسم يا ل مدير ادارة ها لمعنه سال عبدالرسول التفتيش على المستلزمات الطبية a as ey د.رباب " we AYR 1 يب دا mat سل الدوان ال رئيس الإدارة المركزية للعمليات ee he} لاننتيش على المسائع Stl SIC 1 92 سسا تسن a ل ل لتقب اضوع © www.edaegypt.gov.eg 1 من 1 ma | 15301Original language: ar
- Notice text in English
- Not translated. Only the authority's own words above are held.
- Status
- Active
- Superseded by
- Not superseded. This is the current version.
- Version
- 1
Where this record came from, and what is held to show it.
- Copy of the source
- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn. Not yet published at an address you can open.Ask us for it and check it against the fingerprint below.
- Fingerprint
- f1116b2573d56f2b012b579f7d27cfd3267b26e9d1b0e9512bff6bff84757ba0SHA-256 of the copy held. Any file that produces this number is that copy, byte for byte; any file that does not is a different document.
- Copy taken
- 2026-09-06 20:34:48 UTC
Cite this record
Drug Eye Africa (2021). DEA-EG-2021-0011: Engstrom Ventilators — Recall, Egyptian Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/eg/2021/dea-eg-2021-0011Version history
—No version history recorded for this record.
—Corrections appear here and in the site-wide log. Records are superseded, never deleted.
Verification
Tier 1 — Published by the issuing regulator on its own channel and captured by Drug Eye Africa, with the source document archived.
Indexing
This record is indexable: it is dated, names a product, and carries either a batch number or a stated reason.